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Clinical Trial Results:
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (LUCERNE)

Summary
EudraCT number	2018-004042-42
Trial protocol	AT PT DE HU DK ES PL BG IT
Global end of trial date	07 Jan 2022

Results information
Results version number	v1(current)
This version publication date	01 Jan 2023
First version publication date	01 Jan 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GR40844

ISRCTN number

US NCT number

NCT03823300

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche, Ltd.

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland,

Public contact

F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche, Ltd., F. Hoffmann-La Roche, Ltd., +41 616878333, global.trial_information@roche.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

07 Jan 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Oct 2020

Global end of trial reached?

Yes

Global end of trial date

07 Jan 2022

Was the trial ended prematurely?

Main objective of the trial

The main objective of the trial was to evaluate the efficacy and safety of faricimab compared with aflibercept in patients with neovascular age-related macular degeneration.

Protection of trial subjects

This study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. All participants were required to read and sign an informed consent form prior to participation in the study.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Mar 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 66

Country: Number of subjects enrolled

Australia: 38

Country: Number of subjects enrolled

Austria: 14

Country: Number of subjects enrolled

Brazil: 8

Country: Number of subjects enrolled

Bulgaria: 8

Country: Number of subjects enrolled

Denmark: 7

Country: Number of subjects enrolled

France: 26

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Hong Kong: 9

Country: Number of subjects enrolled

Hungary: 33

Country: Number of subjects enrolled

Italy: 12

Country: Number of subjects enrolled

Korea, Republic of: 35

Country: Number of subjects enrolled

Poland: 46

Country: Number of subjects enrolled

Portugal: 9

Country: Number of subjects enrolled

Russian Federation: 16

Country: Number of subjects enrolled

Singapore: 5

Country: Number of subjects enrolled

Spain: 22

Country: Number of subjects enrolled

Taiwan: 19

Country: Number of subjects enrolled

Turkey: 12

Country: Number of subjects enrolled

United States: 267

Worldwide total number of subjects

658

EEA total number of subjects

183

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

492

85 years and over

103

Subject disposition

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Recruitment details

Screening details

A total of 1012 patients were screened, 354 of whom failed screening, most commonly due to not meeting inclusion criteria. A total of 658 treatment-naive patients with nAMD were randomized 1:1 into the study: 331 to the faricimab arm and 327 to the aflibercept arm.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Arm A: Faricimab

Arm description

Subjects randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A subjects with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab (i.e., at Weeks 20, 28, 36, 44, 52, and 60). A second assessment of disease activity at Week 24 required Arm A subjects with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., at Weeks 24, 36, 48, and 60). Subjects who did not have active disease at Weeks 20 and 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W; i.e., at Weeks 28, 44, and 60). From Week 60 (when all of Arm A was scheduled to receive study drug) to Week 108, Arm A subjects were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).

Arm type

Experimental

Investigational medicinal product name

Faricimab

Investigational medicinal product code

RO6867461

Other name

Vabysmo™, VA2, Humanized anti-VEGF-A anti-Ang-2 bispecific Antibody

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Arm B: Aflibercept

Arm description

Subjects randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Subjects were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).

Arm type

Active comparator

Investigational medicinal product name

Aflibercept

Investigational medicinal product code

Other name

Eylea

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Number of subjects in period 1	Arm A: Faricimab	Arm B: Aflibercept
Started	331	327
Received at Least One Dose of Study Drug	331	326
Completed up to Week 48	321	309
Completed	297	273
Not completed	34	54
Consent withdrawn by subject	16	22
Physician decision	1	7
Adverse event, non-fatal	3	5
Death	10	14
Not Specified	1	-
Not Eligible	-	1
Lost to follow-up	1	3
Protocol deviation	1	1
Lack of efficacy	1	1

Baseline characteristics

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Reporting group title

Arm A: Faricimab

Reporting group description

Reporting group title

Arm B: Aflibercept

Reporting group description

Reporting group values	Arm A: Faricimab	Arm B: Aflibercept	Total
Number of subjects	331	327	658
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	30	33	63
From 65-84 years	257	235	492
85 years and over	44	59	103
Age Continuous
Units: Years
arithmetic mean (standard deviation)	74.8 ± 8.4	76.1 ± 8.6	-
Sex: Female, Male
Units: Participants
Female	203	188	391
Male	128	139	267
Race/Ethnicity, Customized
Units: Subjects
White	278	270	548
Asian	38	34	72
Unknown	12	17	29
Black or African American	2	5	7
American Indian or Alaska Native	1	0	1
Multiple	0	1	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	35	46	81
Not Hispanic or Latino	287	274	561
Unknown or Not Reported	9	7	16
Region of Enrollment
Units: Subjects
United States and Canada	135	132	267
Asia	35	33	68
Rest of the World	161	162	323
Number of Participants by the Eye (Right or Left) Chosen as the Study Eye
Units: Subjects
Right Eye	168	170	338
Left Eye	163	157	320
Number of Participants by the BCVA Letter Score Categories in the Study Eye
Units: Subjects
≥74 Letters	45	39	84
73 to 55 Letters	181	183	364
≤54 Letters	105	105	210
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye
Units: Subjects
<33 Letters	238	234	472
≥33 Letters	89	93	182
Missing/Invalid	4	0	4
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Units: Subjects
Occult	171	140	311
Classic	98	109	207
Minimally Classic	30	31	61
Retinal Angiomatous Proliferation (RAP)	14	15	29
Predominantly Classic	6	16	22
Polypoidal Choroidal Vasculopathy (PCV)	5	8	13
Missing	7	8	15
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R). The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Units: ETDRS Letters
arithmetic mean (standard deviation)	58.7 ± 14.0	58.9 ± 13.3	-

End points

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Reporting group title

Arm A: Faricimab

Reporting group description

Reporting group title

Arm B: Aflibercept

Reporting group description

Primary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI

End point type

Primary

End point timeframe

From Baseline through Week 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)	6.6 (5.3 to 7.8)	6.6 (5.3 to 7.8)

Treatment Difference at Weeks 40-48

Statistical analysis description

The null hypothesis, H0: μ(faricimab) − μ(aflibercept) ≤−4 letters; the alternative hypothesis, Ha: μ(faricimab) − μ(aflibercept) >−4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

658

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

Adjusted mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

1.8

Variability estimate

Standard error of the mean

Dispersion value

0.91

Notes
[1] - If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than −4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.

Secondary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

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End point title

Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

End point description

End point type

Secondary

End point timeframe

From Baseline through Week 60

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)	6.6 (5.3 to 7.9)	7.1 (5.8 to 8.4)

Treatment Difference at Weeks 52-60

Statistical analysis description

The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

658

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

1.3

Variability estimate

Standard error of the mean

Dispersion value

0.93

Secondary: Change from Baseline in BCVA in the Study Eye Over Time

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End point title

Change from Baseline in BCVA in the Study Eye Over Time

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)
Week 4	5.1 (4.2 to 5.9)	4.3 (3.5 to 5.2)
Week 8	6.0 (5.1 to 6.9)	5.8 (4.9 to 6.8)
Week 12	7.0 (6.1 to 8.0)	6.4 (5.4 to 7.4)
Week 16	6.7 (5.6 to 7.7)	6.4 (5.4 to 7.4)
Week 20	7.0 (5.9 to 8.1)	6.8 (5.7 to 7.9)
Week 24	7.0 (5.8 to 8.1)	6.5 (5.4 to 7.6)
Week 28	7.1 (5.9 to 8.2)	6.8 (5.6 to 7.9)
Week 32	7.2 (6.0 to 8.3)	6.9 (5.7 to 8.0)
Week 36	6.7 (5.5 to 7.9)	6.8 (5.6 to 8.0)
Week 40	6.8 (5.5 to 8.1)	6.7 (5.4 to 8.0)
Week 44	6.5 (5.3 to 7.8)	6.4 (5.2 to 7.7)
Week 48	6.5 (5.1 to 7.8)	6.4 (5.0 to 7.7)
Week 52	6.4 (5.1 to 7.7)	6.9 (5.5 to 8.3)
Week 56	7.1 (5.7 to 8.4)	7.4 (6.0 to 8.7)
Week 60	6.3 (4.9 to 7.7)	6.9 (5.5 to 8.3)
Week 64	6.5 (5.1 to 8.0)	6.1 (4.7 to 7.6)
Week 68	6.2 (4.8 to 7.6)	6.7 (5.3 to 8.1)
Week 72	6.4 (4.9 to 7.8)	6.2 (4.8 to 7.7)
Week 76	6.4 (4.9 to 7.9)	6.0 (4.6 to 7.5)
Week 80	5.9 (4.4 to 7.4)	5.6 (4.1 to 7.2)
Week 84	5.9 (4.3 to 7.5)	5.8 (4.2 to 7.3)
Week 88	5.6 (4.1 to 7.1)	5.4 (3.9 to 7.0)
Week 92	5.7 (4.2 to 7.2)	5.4 (3.9 to 7.0)
Week 96	5.4 (3.9 to 7.0)	5.5 (3.9 to 7.0)
Week 100	5.2 (3.6 to 6.8)	4.9 (3.3 to 6.5)
Week 104	5.0 (3.4 to 6.6)	5.3 (3.7 to 6.9)
Week 108	5.2 (3.5 to 6.8)	5.4 (3.7 to 7.0)
Week 112	4.8 (3.2 to 6.5)	4.8 (3.1 to 6.5)

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, average of Weeks 40, 44, and 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	302 ^[2]	291 ^[3]
Units: Percentage of participants
number (confidence interval 95%)
Gaining ≥15 Letters	20.2 (15.9 to 24.6)	22.2 (17.7 to 26.8)
Gaining ≥10 Letters	39.2 (34.1 to 44.4)	35.8 (30.6 to 40.9)
Gaining ≥5 Letters	60.5 (55.2 to 65.7)	59.4 (53.9 to 64.9)
Gaining ≥0 Letters	82.2 (77.9 to 86.4)	79.1 (74.5 to 83.6)

Notes
[2] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.
[3] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.

Gaining ≥15 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-8.3

upper limit

4.3

Gaining ≥10 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

10.7

Gaining ≥5 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

8.6

Gaining ≥0 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

9.3

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

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End point title

Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

End point description

End point type

Secondary

End point timeframe

Baseline, average of Weeks 52, 56, and 60

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	289 ^[4]	276 ^[5]
Units: Percentage of participants
number (confidence interval 95%)	22.6 (18.1 to 27.1)	23.7 (19.1 to 28.4)

Notes
[4] - Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60.
[5] - Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60.

Treatment Difference at Weeks 52-60

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-7.7

upper limit

5.3

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

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End point title

Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[6]	327 ^[7]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	10.5 (7.2 to 13.7)	9.5 (6.4 to 12.6)
Week 8 (n = 327, 322)	13.9 (10.3 to 17.5)	13.5 (10.0 to 17.1)
Week 12 (n = 326, 317)	17.7 (13.7 to 21.6)	17.2 (13.3 to 21.1)
Week 16 (n = 321, 315)	17.3 (13.3 to 21.3)	17.7 (13.6 to 21.8)
Week 20 (n = 320, 309)	20.2 (15.9 to 24.4)	20.2 (15.9 to 24.4)
Week 24 (n = 295, 288)	19.3 (14.9 to 23.6)	18.9 (14.6 to 23.3)
Week 28 (n = 292, 271)	23.7 (19.1 to 28.3)	20.8 (16.1 to 25.4)
Week 32 (n = 287, 288)	22.6 (18.0 to 27.2)	19.5 (15.1 to 23.9)
Week 36 (n = 293, 283)	22.2 (17.7 to 26.6)	20.6 (16.1 to 25.0)
Week 40 (n = 286, 288)	23.7 (19.0 to 28.3)	25.4 (20.6 to 30.1)
Week 44 (n = 285, 273)	21.5 (17.1 to 26.0)	22.4 (17.7 to 27.1)
Week 48 (n = 282, 277)	22.3 (17.7 to 26.9)	23.1 (18.3 to 27.8)
Week 52 (n = 283, 273)	22.7 (18.1 to 27.2)	23.4 (18.7 to 28.1)
Week 56 (n = 283, 273)	25.9 (21.1 to 30.7)	27.0 (22.0 to 32.0)
Week 60 (n = 278, 273)	22.6 (18.1 to 27.1)	25.8 (20.9 to 30.7)
Week 64 (n = 276, 266)	25.4 (20.6 to 30.2)	21.2 (16.5 to 25.9)
Week 68 (n = 276, 266)	24.5 (19.7 to 29.3)	24.9 (20.0 to 29.8)
Week 72 (n = 276, 261)	22.6 (17.9 to 27.2)	27.1 (22.0 to 32.1)
Week 76 (n = 268, 267)	22.1 (17.4 to 26.8)	24.9 (20.1 to 29.8)
Week 80 (n = 275, 264)	22.9 (18.1 to 27.7)	25.8 (20.8 to 30.7)
Week 84 (n = 279, 254)	23.7 (18.9 to 28.5)	25.6 (20.6 to 30.6)
Week 88 (n = 276, 253)	24.1 (19.3 to 29.0)	24.4 (19.5 to 29.3)
Week 92 (n = 273, 253)	22.5 (17.8 to 27.2)	24.8 (19.9 to 29.8)
Week 96 (n = 266, 247)	25.7 (20.8 to 30.6)	25.5 (20.5 to 30.6)
Week 100 (n = 272, 254)	24.8 (19.9 to 29.8)	23.1 (18.3 to 28.0)
Week 104 (n = 263, 249)	22.5 (17.7 to 27.3)	24.6 (19.6 to 29.5)
Week 108 (n = 267, 247)	21.6 (16.8 to 26.3)	22.3 (17.5 to 27.1)
Week 112 (n = 267, 254)	25.2 (20.3 to 30.1)	22.5 (17.8 to 27.1)

Notes
[6] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[7] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

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End point title

Percentage of Participants Gaining ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[8]	327 ^[9]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	24.2 (19.8 to 28.7)	22.1 (17.7 to 26.5)
Week 8 (n = 327, 322)	32.4 (27.5 to 37.2)	28.7 (24.1 to 33.4)
Week 12 (n = 326, 317)	34.2 (29.3 to 39.1)	34.6 (29.5 to 39.7)
Week 16 (n = 321, 315)	35.3 (30.3 to 40.4)	34.2 (29.2 to 39.3)
Week 20 (n = 320, 309)	37.8 (32.7 to 42.9)	34.3 (29.2 to 39.4)
Week 24 (n = 295, 288)	39.2 (33.8 to 44.5)	35.2 (29.9 to 40.5)
Week 28 (n = 292, 271)	40.5 (35.1 to 45.8)	36.0 (30.5 to 41.4)
Week 32 (n = 287, 288)	40.5 (35.1 to 46.0)	35.0 (29.7 to 40.3)
Week 36 (n = 293, 283)	38.9 (33.6 to 44.2)	38.9 (33.5 to 44.3)
Week 40 (n = 286, 288)	40.9 (35.5 to 46.3)	39.3 (34.0 to 44.7)
Week 44 (n = 285, 273)	42.3 (36.8 to 47.8)	39.5 (34.1 to 45.0)
Week 48 (n = 282, 277)	41.0 (35.5 to 46.5)	38.6 (33.2 to 43.9)
Week 52 (n = 283, 273)	44.2 (38.8 to 49.7)	42.1 (36.6 to 47.6)
Week 56 (n = 283, 273)	44.2 (38.8 to 49.7)	43.6 (38.1 to 49.2)
Week 60 (n = 278, 273)	43.1 (37.6 to 48.6)	42.4 (36.8 to 47.9)
Week 64 (n = 276, 266)	44.0 (38.5 to 49.5)	41.1 (35.4 to 46.8)
Week 68 (n = 276, 266)	40.1 (34.7 to 45.5)	40.7 (35.3 to 46.2)
Week 72 (n = 276, 261)	42.0 (36.5 to 47.4)	38.9 (33.4 to 44.3)
Week 76 (n = 268, 267)	42.2 (36.7 to 47.8)	40.7 (35.1 to 46.2)
Week 80 (n = 275, 264)	44.2 (38.6 to 49.9)	41.9 (36.2 to 47.6)
Week 84 (n = 279, 254)	42.7 (37.2 to 48.3)	41.4 (35.6 to 47.2)
Week 88 (n = 276, 253)	40.3 (34.8 to 45.9)	39.4 (33.7 to 45.1)
Week 92 (n = 273, 253)	42.1 (36.5 to 47.8)	41.0 (35.3 to 46.7)
Week 96 (n = 266, 247)	41.1 (35.5 to 46.7)	39.1 (33.3 to 45.0)
Week 100 (n = 272, 254)	40.2 (34.6 to 45.7)	34.6 (29.0 to 40.1)
Week 104 (n = 263, 249)	44.0 (38.3 to 49.7)	36.2 (30.5 to 41.9)
Week 108 (n = 267, 247)	41.7 (36.0 to 47.4)	38.0 (32.2 to 43.8)
Week 112 (n = 267, 254)	41.3 (35.7 to 47.0)	35.0 (29.6 to 40.5)

Notes
[8] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[9] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

Top of page

End point title

Percentage of Participants Gaining ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[10]	327 ^[11]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	47.8 (42.6 to 53.0)	47.5 (42.2 to 52.8)
Week 8 (n = 327, 322)	56.8 (51.6 to 62.0)	54.6 (49.3 to 59.8)
Week 12 (n = 326, 317)	63.9 (58.9 to 68.9)	57.6 (52.3 to 62.9)
Week 16 (n = 321, 315)	61.7 (56.5 to 66.8)	59.6 (54.3 to 64.9)
Week 20 (n = 320, 309)	64.1 (59.0 to 69.2)	60.9 (55.6 to 66.3)
Week 24 (n = 295, 288)	62.2 (56.8 to 67.6)	60.2 (54.7 to 65.7)
Week 28 (n = 292, 271)	63.6 (58.2 to 68.9)	60.5 (54.8 to 66.2)
Week 32 (n = 287, 288)	63.3 (58.0 to 68.7)	60.1 (54.6 to 65.6)
Week 36 (n = 293, 283)	61.4 (56.0 to 66.9)	60.4 (54.9 to 65.9)
Week 40 (n = 286, 288)	63.5 (58.1 to 68.9)	60.9 (55.5 to 66.4)
Week 44 (n = 285, 273)	60.1 (54.6 to 65.6)	62.3 (56.7 to 67.8)
Week 48 (n = 282, 277)	60.0 (54.5 to 65.6)	63.5 (57.9 to 69.1)
Week 52 (n = 283, 273)	63.5 (58.1 to 69.0)	67.2 (61.7 to 72.6)
Week 56 (n = 283, 273)	64.1 (58.7 to 69.5)	66.5 (61.0 to 72.0)
Week 60 (n = 278, 273)	61.6 (56.1 to 67.2)	65.5 (59.9 to 71.0)
Week 64 (n = 276, 266)	65.2 (59.8 to 70.6)	63.1 (57.5 to 68.8)
Week 68 (n = 276, 266)	63.0 (57.4 to 68.5)	64.0 (58.5 to 69.6)
Week 72 (n = 276, 261)	64.1 (58.6 to 69.6)	66.6 (60.9 to 72.2)
Week 76 (n = 268, 267)	63.9 (58.2 to 69.6)	58.7 (53.0 to 64.4)
Week 80 (n = 275, 264)	63.3 (57.7 to 68.9)	62.3 (56.6 to 67.9)
Week 84 (n = 279, 254)	61.6 (56.1 to 67.2)	64.3 (58.6 to 70.1)
Week 88 (n = 276, 253)	62.6 (57.1 to 68.1)	60.7 (54.9 to 66.5)
Week 92 (n = 273, 253)	62.7 (57.1 to 68.3)	58.3 (52.6 to 64.0)
Week 96 (n = 266, 247)	61.3 (55.6 to 67.0)	61.0 (55.1 to 67.0)
Week 100 (n = 272, 254)	61.7 (56.1 to 67.3)	56.9 (50.9 to 62.9)
Week 104 (n = 263, 249)	60.3 (54.6 to 66.0)	59.3 (53.3 to 65.3)
Week 108 (n = 267, 247)	62.4 (56.8 to 68.0)	58.0 (51.8 to 64.1)
Week 112 (n = 267, 254)	59.9 (54.2 to 65.6)	59.4 (53.4 to 65.3)

Notes
[10] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[11] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining ≥0 Letters from the Baseline BCVA in the Study Eye Over Time

Top of page

End point title

Percentage of Participants Gaining ≥0 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[12]	327 ^[13]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	80.5 (76.3 to 84.7)	74.2 (69.5 to 78.9)
Week 8 (n = 327, 322)	82.3 (78.3 to 86.3)	80.3 (76.0 to 84.5)
Week 12 (n = 326, 317)	84.1 (80.3 to 88.0)	81.0 (76.8 to 85.1)
Week 16 (n = 321, 315)	82.6 (78.5 to 86.6)	83.0 (78.9 to 87.0)
Week 20 (n = 320, 309)	84.8 (80.9 to 88.6)	83.1 (79.1 to 87.2)
Week 24 (n = 295, 288)	82.8 (78.6 to 86.9)	82.0 (77.6 to 86.4)
Week 28 (n = 292, 271)	82.7 (78.5 to 86.8)	83.0 (78.7 to 87.4)
Week 32 (n = 287, 288)	80.3 (75.9 to 84.7)	82.2 (77.8 to 86.5)
Week 36 (n = 293, 283)	81.2 (76.8 to 85.6)	76.5 (71.7 to 81.3)
Week 40 (n = 286, 288)	82.0 (77.6 to 86.3)	77.6 (72.9 to 82.3)
Week 44 (n = 285, 273)	84.0 (79.8 to 88.2)	78.6 (73.9 to 83.2)
Week 48 (n = 282, 277)	82.7 (78.3 to 87.1)	78.9 (74.1 to 83.6)
Week 52 (n = 283, 273)	79.4 (74.8 to 84.0)	84.7 (80.5 to 88.9)
Week 56 (n = 283, 273)	80.7 (76.1 to 85.2)	82.6 (78.2 to 87.0)
Week 60 (n = 278, 273)	78.9 (74.2 to 83.6)	81.5 (77.0 to 86.0)
Week 64 (n = 276, 266)	81.3 (76.8 to 85.8)	81.1 (76.5 to 85.7)
Week 68 (n = 276, 266)	80.5 (76.0 to 85.1)	80.4 (75.8 to 85.0)
Week 72 (n = 276, 261)	79.5 (74.8 to 84.1)	78.8 (74.0 to 83.6)
Week 76 (n = 268, 267)	81.0 (76.4 to 85.6)	79.8 (75.2 to 84.5)
Week 80 (n = 275, 264)	80.0 (75.3 to 84.7)	76.0 (71.0 to 81.1)
Week 84 (n = 279, 254)	78.7 (73.9 to 83.5)	81.0 (76.3 to 85.7)
Week 88 (n = 276, 253)	78.7 (73.9 to 83.5)	80.6 (75.9 to 85.4)
Week 92 (n = 273, 253)	81.3 (76.7 to 85.8)	76.3 (71.2 to 81.4)
Week 96 (n = 266, 247)	76.3 (71.3 to 81.3)	77.5 (72.5 to 82.6)
Week 100 (n = 272, 254)	75.7 (70.8 to 80.7)	74.8 (69.6 to 80.0)
Week 104 (n = 263, 249)	76.6 (71.6 to 81.6)	79.0 (74.0 to 84.0)
Week 108 (n = 267, 247)	78.8 (74.0 to 83.6)	76.9 (71.7 to 82.1)
Week 112 (n = 267, 254)	74.6 (69.5 to 79.8)	77.4 (72.3 to 82.5)

Notes
[12] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[13] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, average of Weeks 40, 44, and 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	302 ^[14]	291 ^[15]
Units: Percentage of participants
number (confidence interval 95%)
Avoiding a Loss of ≥15 Letters	95.8 (93.6 to 98.0)	97.3 (95.5 to 99.1)
Avoiding a Loss of ≥10 Letters	93.8 (91.1 to 96.4)	94.6 (92.2 to 97.1)
Avoiding a Loss of ≥5 Letters	91.2 (88.0 to 94.3)	88.5 (85.0 to 92.0)

Notes
[14] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.
[15] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.

Avoiding a Loss of ≥15 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

1.3

Avoiding a Loss of ≥5 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

7.3

Avoiding a Loss of ≥10 Letters at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

2.8

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

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End point title

Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

End point description

End point type

Secondary

End point timeframe

Baseline, average of Weeks 52, 56, and 60

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	289 ^[16]	276 ^[17]
Units: Percentage of participants
number (confidence interval 95%)	96.5 (94.4 to 98.6)	96.1 (94.0 to 98.3)

Notes
[16] - Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60.
[17] - Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60.

Treatment Difference at Weeks 52-60

Statistical analysis description

The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

565

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

3.3

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

Top of page

End point title

Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[18]	327 ^[19]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	99.4 (98.6 to 100.0)	98.1 (96.7 to 99.6)
Week 8 (n = 327, 322)	98.5 (97.3 to 99.8)	97.8 (96.3 to 99.4)
Week 12 (n = 326, 317)	98.5 (97.3 to 99.8)	98.1 (96.7 to 99.6)
Week 16 (n = 321, 315)	97.6 (96.0 to 99.2)	98.4 (97.0 to 99.8)
Week 20 (n = 320, 309)	97.3 (95.5 to 99.0)	98.4 (97.0 to 99.7)
Week 24 (n = 295, 288)	96.6 (94.6 to 98.6)	97.2 (95.4 to 99.1)
Week 28 (n = 292, 271)	97.0 (95.1 to 98.9)	97.8 (96.2 to 99.5)
Week 32 (n = 287, 288)	97.0 (95.1 to 98.9)	96.9 (95.0 to 98.9)
Week 36 (n = 293, 283)	97.0 (95.2 to 98.9)	96.5 (94.5 to 98.6)
Week 40 (n = 286, 288)	96.2 (94.1 to 98.4)	97.6 (95.9 to 99.3)
Week 44 (n = 285, 273)	95.9 (93.6 to 98.1)	96.4 (94.3 to 98.5)
Week 48 (n = 282, 277)	95.8 (93.5 to 98.0)	96.9 (95.0 to 98.8)
Week 52 (n = 283, 273)	94.9 (92.5 to 97.4)	96.8 (94.8 to 98.8)
Week 56 (n = 283, 273)	96.1 (93.9 to 98.3)	96.8 (94.8 to 98.8)
Week 60 (n = 278, 273)	95.0 (92.5 to 97.5)	96.1 (94.0 to 98.3)
Week 64 (n = 276, 266)	96.4 (94.3 to 98.5)	94.9 (92.3 to 97.4)
Week 68 (n = 276, 266)	94.7 (92.1 to 97.2)	96.0 (93.7 to 98.3)
Week 72 (n = 276, 261)	94.5 (91.9 to 97.2)	95.4 (92.9 to 97.9)
Week 76 (n = 268, 267)	94.9 (92.3 to 97.4)	93.7 (90.9 to 96.6)
Week 80 (n = 275, 264)	93.9 (91.1 to 96.6)	93.3 (90.4 to 96.3)
Week 84 (n = 279, 254)	92.5 (89.5 to 95.5)	93.8 (90.9 to 96.7)
Week 88 (n = 276, 253)	94.1 (91.4 to 96.7)	94.3 (91.5 to 97.0)
Week 92 (n = 273, 253)	93.0 (90.2 to 95.9)	94.6 (92.0 to 97.2)
Week 96 (n = 266, 247)	92.6 (89.6 to 95.6)	95.0 (92.5 to 97.6)
Week 100 (n = 272, 254)	92.5 (89.5 to 95.5)	93.9 (91.1 to 96.7)
Week 104 (n = 263, 249)	92.9 (90.0 to 95.9)	94.0 (91.0 to 96.9)
Week 108 (n = 267, 247)	92.3 (89.2 to 95.3)	93.3 (90.3 to 96.3)
Week 112 (n = 267, 254)	91.8 (88.7 to 95.0)	93.0 (89.9 to 96.1)

Notes
[18] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[19] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Avoiding a Loss of ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

Top of page

End point title

Percentage of Participants Avoiding a Loss of ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[20]	327 ^[21]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	98.5 (97.2 to 99.8)	96.2 (94.1 to 98.3)
Week 8 (n = 327, 322)	97.0 (95.3 to 98.7)	96.9 (95.0 to 98.7)
Week 12 (n = 326, 317)	97.0 (95.2 to 98.8)	96.8 (94.9 to 98.7)
Week 16 (n = 321, 315)	96.6 (94.7 to 98.5)	96.8 (94.9 to 98.7)
Week 20 (n = 320, 309)	95.2 (92.9 to 97.4)	96.1 (94.0 to 98.2)
Week 24 (n = 295, 288)	95.2 (92.9 to 97.6)	95.5 (93.2 to 97.8)
Week 28 (n = 292, 271)	95.0 (92.6 to 97.4)	95.2 (92.7 to 97.7)
Week 32 (n = 287, 288)	94.6 (92.1 to 97.1)	95.9 (93.7 to 98.1)
Week 36 (n = 293, 283)	95.3 (93.0 to 97.7)	94.4 (91.8 to 97.0)
Week 40 (n = 286, 288)	93.8 (91.1 to 96.5)	94.6 (92.2 to 97.1)
Week 44 (n = 285, 273)	94.1 (91.4 to 96.8)	92.1 (89.1 to 95.1)
Week 48 (n = 282, 277)	92.2 (89.2 to 95.3)	94.8 (92.3 to 97.3)
Week 52 (n = 283, 273)	91.4 (88.2 to 94.6)	93.8 (91.1 to 96.6)
Week 56 (n = 283, 273)	93.3 (90.5 to 96.2)	95.0 (92.5 to 97.5)
Week 60 (n = 278, 273)	91.4 (88.2 to 94.6)	93.2 (90.4 to 96.1)
Week 64 (n = 276, 266)	93.5 (90.7 to 96.4)	92.3 (89.3 to 95.4)
Week 68 (n = 276, 266)	91.9 (88.8 to 95.0)	92.9 (89.9 to 96.0)
Week 72 (n = 276, 261)	92.4 (89.3 to 95.5)	91.6 (88.3 to 94.9)
Week 76 (n = 268, 267)	93.1 (90.2 to 96.0)	90.1 (86.5 to 93.6)
Week 80 (n = 275, 264)	92.1 (89.0 to 95.2)	89.9 (86.3 to 93.5)
Week 84 (n = 279, 254)	90.3 (86.9 to 93.7)	91.8 (88.4 to 95.1)
Week 88 (n = 276, 253)	90.8 (87.5 to 94.1)	92.3 (89.1 to 95.4)
Week 92 (n = 273, 253)	90.7 (87.4 to 94.1)	91.0 (87.6 to 94.5)
Week 96 (n = 266, 247)	90.4 (87.0 to 93.8)	92.6 (89.4 to 95.8)
Week 100 (n = 272, 254)	90.7 (87.4 to 94.0)	91.6 (88.3 to 94.9)
Week 104 (n = 263, 249)	89.0 (85.4 to 92.7)	92.2 (88.9 to 95.4)
Week 108 (n = 267, 247)	88.5 (84.8 to 92.3)	91.2 (87.7 to 94.7)
Week 112 (n = 267, 254)	88.5 (84.7 to 92.2)	89.5 (85.8 to 93.2)

Notes
[20] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[21] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Avoiding a Loss of ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

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End point title

Percentage of Participants Avoiding a Loss of ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[22]	327 ^[23]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	93.0 (90.4 to 95.6)	91.8 (88.9 to 94.7)
Week 8 (n = 327, 322)	93.1 (90.4 to 95.7)	94.1 (91.5 to 96.6)
Week 12 (n = 326, 317)	93.3 (90.7 to 95.9)	91.8 (88.8 to 94.7)
Week 16 (n = 321, 315)	91.7 (88.7 to 94.6)	90.8 (87.7 to 94.0)
Week 20 (n = 320, 309)	92.0 (89.1 to 94.9)	92.9 (90.0 to 95.7)
Week 24 (n = 295, 288)	90.6 (87.4 to 93.9)	91.7 (88.6 to 94.8)
Week 28 (n = 292, 271)	91.0 (87.9 to 94.1)	90.2 (86.7 to 93.7)
Week 32 (n = 287, 288)	89.9 (86.5 to 93.2)	91.0 (87.7 to 94.3)
Week 36 (n = 293, 283)	90.7 (87.5 to 94.0)	87.4 (83.6 to 91.2)
Week 40 (n = 286, 288)	91.7 (88.6 to 94.9)	88.1 (84.5 to 91.7)
Week 44 (n = 285, 273)	90.9 (87.7 to 94.2)	88.8 (85.3 to 92.3)
Week 48 (n = 282, 277)	89.4 (85.9 to 93.0)	88.6 (85.0 to 92.2)
Week 52 (n = 283, 273)	88.9 (85.3 to 92.5)	91.7 (88.6 to 94.8)
Week 56 (n = 283, 273)	89.5 (86.0 to 93.0)	88.8 (85.2 to 92.5)
Week 60 (n = 278, 273)	86.7 (82.9 to 90.6)	88.8 (85.2 to 92.4)
Week 64 (n = 276, 266)	87.8 (84.1 to 91.6)	86.0 (82.0 to 90.1)
Week 68 (n = 276, 266)	88.2 (84.5 to 91.9)	87.1 (83.2 to 91.0)
Week 72 (n = 276, 261)	87.0 (83.1 to 90.9)	87.3 (83.4 to 91.2)
Week 76 (n = 268, 267)	87.1 (83.2 to 91.1)	85.4 (81.2 to 89.5)
Week 80 (n = 275, 264)	87.3 (83.5 to 91.2)	82.8 (78.3 to 87.3)
Week 84 (n = 279, 254)	84.1 (79.9 to 88.4)	87.1 (83.1 to 91.2)
Week 88 (n = 276, 253)	87.5 (83.7 to 91.3)	86.6 (82.5 to 90.6)
Week 92 (n = 273, 253)	87.0 (83.1 to 90.9)	87.2 (83.2 to 91.2)
Week 96 (n = 266, 247)	82.7 (78.4 to 87.1)	86.2 (82.1 to 90.4)
Week 100 (n = 272, 254)	85.9 (81.9 to 89.8)	84.2 (79.9 to 88.5)
Week 104 (n = 263, 249)	83.5 (79.1 to 87.8)	85.4 (81.1 to 89.7)
Week 108 (n = 267, 247)	84.1 (79.9 to 88.4)	83.9 (79.4 to 88.5)
Week 112 (n = 267, 254)	82.2 (77.7 to 86.7)	84.4 (80.0 to 88.8)

Notes
[22] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[23] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

End point type

Secondary

End point timeframe

Baseline, average of Weeks 40, 44, and 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	302 ^[24]	291 ^[25]
Units: Percentage of participants
number (confidence interval 95%)	24.5 (19.8 to 29.2)	26.2 (21.2 to 31.1)

Notes
[24] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.
[25] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.

Treatment Difference at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-8.5

upper limit

5.1

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time

Top of page

End point title

Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[26]	327 ^[27]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	11.3 (7.9 to 14.6)	12.4 (8.9 to 15.9)
Week 8 (n = 327, 322)	16.5 (12.5 to 20.4)	16.1 (12.2 to 20.0)
Week 12 (n = 326, 317)	22.0 (17.7 to 26.4)	21.1 (16.7 to 25.4)
Week 16 (n = 321, 315)	21.7 (17.4 to 26.1)	20.7 (16.2 to 25.1)
Week 20 (n = 320, 309)	24.9 (20.2 to 29.5)	24.9 (20.2 to 29.6)
Week 24 (n = 295, 288)	23.6 (18.9 to 28.3)	23.7 (18.9 to 28.6)
Week 28 (n = 292, 271)	27.7 (22.7 to 32.7)	26.9 (21.8 to 32.1)
Week 32 (n = 287, 288)	28.7 (23.6 to 33.8)	23.2 (18.4 to 27.9)
Week 36 (n = 293, 283)	25.9 (21.1 to 30.7)	24.6 (19.7 to 29.5)
Week 40 (n = 286, 288)	27.9 (22.9 to 32.9)	31.1 (25.9 to 36.4)
Week 44 (n = 285, 273)	27.2 (22.2 to 32.1)	28.1 (22.8 to 33.3)
Week 48 (n = 282, 277)	27.3 (22.3 to 32.4)	28.3 (23.1 to 33.6)
Week 52 (n = 283, 273)	29.2 (24.1 to 34.3)	28.3 (23.1 to 33.5)
Week 56 (n = 283, 273)	32.0 (26.7 to 37.2)	31.5 (26.1 to 36.9)
Week 60 (n = 278, 273)	27.5 (22.5 to 32.5)	31.4 (26.0 to 36.8)
Week 64 (n = 276, 266)	30.1 (25.0 to 35.3)	27.1 (21.9 to 32.3)
Week 68 (n = 276, 266)	28.3 (23.1 to 33.4)	30.0 (24.6 to 35.3)
Week 72 (n = 276, 261)	26.4 (21.4 to 31.4)	31.5 (26.0 to 36.9)
Week 76 (n = 268, 267)	27.4 (22.2 to 32.5)	29.2 (23.9 to 34.4)
Week 80 (n = 275, 264)	28.7 (23.4 to 34.0)	31.2 (25.7 to 36.6)
Week 84 (n = 279, 254)	28.0 (22.8 to 33.1)	30.1 (24.6 to 35.5)
Week 88 (n = 276, 253)	29.1 (23.8 to 34.4)	28.4 (23.2 to 33.6)
Week 92 (n = 273, 253)	27.0 (21.8 to 32.1)	29.0 (23.6 to 34.3)
Week 96 (n = 266, 247)	30.7 (25.3 to 36.0)	31.1 (25.5 to 36.6)
Week 100 (n = 272, 254)	28.6 (23.3 to 33.9)	27.2 (22.0 to 32.5)
Week 104 (n = 263, 249)	27.2 (22.0 to 32.4)	30.2 (24.8 to 35.6)
Week 108 (n = 267, 247)	26.3 (21.1 to 31.4)	27.0 (21.7 to 32.4)
Week 112 (n = 267, 254)	29.4 (24.1 to 34.7)	26.5 (21.4 to 31.6)

Notes
[26] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[27] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI

End point type

Secondary

End point timeframe

Baseline, average of Weeks 40, 44, and 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	302 ^[28]	291 ^[29]
Units: Percentage of participants
number (confidence interval 95%)	55.2 (50.1 to 60.2)	49.4 (44.4 to 54.4)

Notes
[28] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.
[29] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.

Treatment Difference at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

12.9

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time

Top of page

End point title

Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[30]	327 ^[31]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	45.7 (41.1 to 50.2)	40.1 (35.8 to 44.5)
Week 8 (n = 327, 322)	50.5 (45.8 to 55.1)	45.2 (40.7 to 49.7)
Week 12 (n = 326, 317)	53.5 (48.8 to 58.3)	48.5 (43.8 to 53.3)
Week 16 (n = 321, 315)	56.1 (51.2 to 60.9)	47.4 (42.8 to 52.1)
Week 20 (n = 320, 309)	57.5 (52.6 to 62.4)	51.1 (46.3 to 55.9)
Week 24 (n = 295, 288)	57.4 (52.4 to 62.4)	47.8 (42.9 to 52.8)
Week 28 (n = 292, 271)	55.2 (50.0 to 60.4)	48.2 (43.2 to 53.2)
Week 32 (n = 287, 288)	55.9 (50.8 to 61.1)	49.8 (45.0 to 54.6)
Week 36 (n = 293, 283)	56.0 (50.9 to 61.0)	47.4 (42.2 to 52.6)
Week 40 (n = 286, 288)	54.7 (49.5 to 59.9)	52.7 (47.5 to 57.9)
Week 44 (n = 285, 273)	56.3 (51.4 to 61.3)	52.5 (47.3 to 57.7)
Week 48 (n = 282, 277)	55.0 (49.8 to 60.2)	52.3 (47.1 to 57.5)
Week 52 (n = 283, 273)	55.9 (50.6 to 61.1)	55.6 (50.4 to 60.9)
Week 56 (n = 283, 273)	57.1 (51.8 to 62.3)	52.9 (47.7 to 58.2)
Week 60 (n = 278, 273)	53.0 (47.6 to 58.3)	53.6 (48.3 to 58.9)
Week 64 (n = 276, 266)	58.8 (53.5 to 64.2)	52.9 (47.5 to 58.3)
Week 68 (n = 276, 266)	57.0 (51.7 to 62.4)	55.5 (50.0 to 60.9)
Week 72 (n = 276, 261)	58.1 (52.7 to 63.4)	53.3 (48.0 to 58.6)
Week 76 (n = 268, 267)	58.0 (52.6 to 63.4)	54.0 (48.6 to 59.3)
Week 80 (n = 275, 264)	57.3 (52.0 to 62.6)	51.9 (46.5 to 57.4)
Week 84 (n = 279, 254)	58.4 (53.1 to 63.7)	56.9 (51.5 to 62.4)
Week 88 (n = 276, 253)	57.2 (51.9 to 62.6)	51.1 (45.6 to 56.5)
Week 92 (n = 273, 253)	56.1 (50.8 to 61.4)	54.9 (49.5 to 60.3)
Week 96 (n = 266, 247)	55.5 (49.9 to 61.0)	53.9 (48.4 to 59.4)
Week 100 (n = 272, 254)	55.1 (49.5 to 60.7)	51.7 (46.2 to 57.2)
Week 104 (n = 263, 249)	55.1 (49.4 to 60.7)	52.8 (47.3 to 58.2)
Week 108 (n = 267, 247)	54.8 (49.1 to 60.4)	51.0 (45.5 to 56.5)
Week 112 (n = 267, 254)	55.7 (50.2 to 61.1)	51.0 (45.6 to 56.4)

Notes
[30] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[31] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

End point type

Secondary

End point timeframe

Baseline, average of Weeks 40, 44, and 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	302 ^[32]	291 ^[33]
Units: Percentage of participants
number (confidence interval 95%)	7.9 (5.0 to 10.8)	7.5 (4.7 to 10.3)

Notes
[32] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.
[33] - Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48.

Treatment Difference at Weeks 40-48

Statistical analysis description

The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

593

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

4.4

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time

Top of page

End point title

Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time

End point description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[34]	327 ^[35]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 328, 323)	6.8 (4.3 to 9.4)	6.1 (3.7 to 8.5)
Week 8 (n = 327, 322)	7.4 (4.8 to 10.1)	6.2 (3.7 to 8.6)
Week 12 (n = 326, 317)	7.6 (5.0 to 10.2)	5.9 (3.5 to 8.3)
Week 16 (n = 321, 315)	9.5 (6.6 to 12.5)	5.3 (3.0 to 7.6)
Week 20 (n = 320, 309)	9.3 (6.4 to 12.3)	5.7 (3.3 to 8.1)
Week 24 (n = 295, 288)	8.1 (5.2 to 11.1)	6.3 (3.7 to 8.9)
Week 28 (n = 292, 271)	7.4 (4.6 to 10.3)	6.4 (3.7 to 9.1)
Week 32 (n = 287, 288)	8.1 (5.1 to 11.0)	6.6 (4.0 to 9.2)
Week 36 (n = 293, 283)	7.8 (4.9 to 10.6)	6.8 (4.1 to 9.5)
Week 40 (n = 286, 288)	8.3 (5.3 to 11.3)	7.6 (4.8 to 10.3)
Week 44 (n = 285, 273)	7.9 (4.9 to 10.9)	6.8 (4.0 to 9.5)
Week 48 (n = 282, 277)	9.7 (6.5 to 12.9)	6.3 (3.6 to 9.0)
Week 52 (n = 283, 273)	9.1 (6.0 to 12.2)	6.5 (3.7 to 9.2)
Week 56 (n = 283, 273)	8.1 (5.1 to 11.1)	6.3 (3.6 to 9.0)
Week 60 (n = 278, 273)	8.2 (5.2 to 11.3)	7.3 (4.5 to 10.2)
Week 64 (n = 276, 266)	7.1 (4.2 to 10.1)	7.2 (4.3 to 10.1)
Week 68 (n = 276, 266)	8.8 (5.6 to 12.0)	6.8 (4.0 to 9.6)
Week 72 (n = 276, 261)	8.4 (5.2 to 11.6)	6.2 (3.4 to 8.9)
Week 76 (n = 268, 267)	9.5 (6.2 to 12.9)	7.4 (4.5 to 10.3)
Week 80 (n = 275, 264)	9.8 (6.5 to 13.1)	8.4 (5.3 to 11.5)
Week 84 (n = 279, 254)	9.3 (6.0 to 12.6)	7.2 (4.2 to 10.1)
Week 88 (n = 276, 253)	8.4 (5.2 to 11.6)	7.5 (4.5 to 10.4)
Week 92 (n = 273, 253)	8.9 (5.6 to 12.2)	9.0 (5.8 to 12.2)
Week 96 (n = 266, 247)	10.4 (6.8 to 13.9)	9.7 (6.5 to 13.0)
Week 100 (n = 272, 254)	10.3 (6.8 to 13.8)	10.9 (7.5 to 14.4)
Week 104 (n = 263, 249)	9.2 (5.8 to 12.6)	9.8 (6.4 to 13.1)
Week 108 (n = 267, 247)	9.5 (6.0 to 12.9)	10.0 (6.5 to 13.4)
Week 112 (n = 267, 254)	9.0 (5.7 to 12.4)	10.6 (7.1 to 14.0)

Notes
[34] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[35] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48

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End point title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48 ^[36]

End point description

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Week 48

Notes
[36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants who were randomized to Arm A: Faricimab.

End point values	Arm A: Faricimab
Number of subjects analysed	316
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	22.2 (17.6 to 26.7)
Once Every 12 Weeks	32.9 (27.7 to 38.1)
Once Every 16 Weeks	44.9 (39.4 to 50.4)

No statistical analyses for this end point

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60

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End point title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60 ^[37]

End point description

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Week 60

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants who were randomized to Arm A: Faricimab.

End point values	Arm A: Faricimab
Number of subjects analysed	305
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	21.6 (17.0 to 26.3)
Once Every 12 Weeks	32.8 (27.5 to 38.1)
Once Every 16 Weeks	45.6 (40.0 to 51.2)

No statistical analyses for this end point

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112

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End point title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112 ^[38]

End point description

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Weeks 108 and 112

Notes
[38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants who were randomized to Arm A: Faricimab.

End point values	Arm A: Faricimab
Number of subjects analysed	287
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	18.8 (14.3 to 23.3)
Once Every 12 Weeks	14.3 (10.2 to 18.3)
Once Every 16 Weeks	66.9 (61.4 to 72.4)

No statistical analyses for this end point

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 48

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End point title

Number of Study Drug Injections Received in the Study Eye Through Week 48

End point description

This analysis was performed on the safety-evaluable population, which included all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.

End point type

Secondary

End point timeframe

From Baseline through Week 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Injections
median (full range (min-max))	6.0 (1 to 8)	8.0 (1 to 8)

No statistical analyses for this end point

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 60

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End point title

Number of Study Drug Injections Received in the Study Eye Through Week 60

End point description

This analysis was performed on the safety-evaluable population, which included all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.

End point type

Secondary

End point timeframe

From Baseline through Week 60

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Injections
median (full range (min-max))	7.0 (1 to 10)	9.0 (1 to 9)

No statistical analyses for this end point

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 108

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End point title

Number of Study Drug Injections Received in the Study Eye Through Week 108

End point description

This analysis was performed on the safety-evaluable population, which included all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.

End point type

Secondary

End point timeframe

From Baseline through Week 108

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Injections
median (full range (min-max))	10.0 (1 to 16)	15.0 (1 to 15)

No statistical analyses for this end point

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

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End point title

Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

End point description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group iteraction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

From Baseline through Week 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: microns
arithmetic mean (confidence interval 95%)	-137.1 (-143.1 to -131.2)	-130.8 (-136.8 to -124.8)

Treatment Difference at Weeks 40-48

Statistical analysis description

The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

658

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

-6.4

Confidence interval

level

95%

sides

2-sided

lower limit

-14.8

upper limit

2.1

Variability estimate

Standard error of the mean

Dispersion value

4.3

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

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End point title

Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

End point description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

From Baseline through Week 60

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: microns
arithmetic mean (confidence interval 95%)	-135.7 (-141.2 to -130.1)	-137.0 (-142.7 to -131.3)

Treatment Difference at Weeks 52-60

Statistical analysis description

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

658

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

9.3

Variability estimate

Standard error of the mean

Dispersion value

4.05

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Over Time

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End point title

Change from Baseline in Central Subfield Thickness in the Study Eye Over Time

End point description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	327
Units: microns
arithmetic mean (confidence interval 95%)
Week 4	-126.5 (-132.3 to -120.6)	-113.9 (-119.8 to -108.0)
Week 8	-138.0 (-143.7 to -132.3)	-123.8 (-129.6 to -118.0)
Week 12	-141.7 (-147.1 to -136.3)	-129.6 (-135.0 to -124.1)
Week 16	-143.7 (-150.3 to -137.1)	-112.9 (-119.6 to -106.2)
Week 20	-130.9 (-136.8 to -125.0)	-132.9 (-138.8 to -126.9)
Week 24	-130.1 (-137.1 to -123.1)	-112.2 (-119.3 to -105.2)
Week 28	-127.3 (-134.0 to -120.6)	-130.1 (-136.9 to -123.3)
Week 32	-138.6 (-145.8 to -131.5)	-115.3 (-122.5 to -108.1)
Week 36	-124.6 (-131.3 to -118.0)	-135.2 (-141.9 to -128.5)
Week 40	-142.5 (-149.3 to -135.6)	-122.5 (-129.4 to -115.6)
Week 44	-130.9 (-136.7 to -125.1)	-141.6 (-147.6 to -135.7)
Week 48	-135.5 (-142.3 to -128.6)	-123.9 (-130.8 to -117.0)
Week 52	-140.9 (-146.4 to -135.3)	-139.6 (-145.3 to -134.0)
Week 56	-138.9 (-145.7 to -132.1)	-125.6 (-132.5 to -118.6)
Week 60	-125.9 (-132.0 to -119.7)	-142.3 (-148.6 to -136.1)
Week 64	-143.8 (-150.3 to -137.2)	-126.0 (-132.7 to -119.3)
Week 68	-138.0 (-143.9 to -132.2)	-138.8 (-144.8 to -132.8)
Week 72	-140.7 (-147.3 to -134.1)	-128.8 (-135.5 to -122.0)
Week 76	-136.1 (-142.4 to -129.7)	-139.0 (-145.4 to -132.6)
Week 80	-144.4 (-151.1 to -137.8)	-128.7 (-135.5 to -121.9)
Week 84	-143.5 (-149.2 to -137.8)	-143.2 (-149.1 to -137.4)
Week 88	-145.5 (-151.6 to -139.5)	-133.3 (-139.5 to -127.1)
Week 92	-142.1 (-148.0 to -136.1)	-143.2 (-149.3 to -137.1)
Week 96	-146.8 (-153.1 to -140.4)	-134.7 (-141.2 to -128.2)
Week 100	-145.0 (-151.7 to -138.3)	-146.2 (-153.1 to -139.3)
Week 104	-149.6 (-156.3 to -142.8)	-137.4 (-144.3 to -130.5)
Week 108	-148.5 (-154.4 to -142.6)	-148.3 (-154.4 to -142.2)
Week 112	-152.9 (-159.2 to -146.7)	-139.1 (-145.5 to -132.7)

No statistical analyses for this end point

Secondary: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye Over Time

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End point title

Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye Over Time

End point description

Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre [mm]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[39]	327 ^[40]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 324, 320)	86.9 (83.5 to 90.4)	82.9 (78.9 to 87.0)
Week 8 (n = 324, 316)	88.5 (85.2 to 91.9)	84.6 (80.7 to 88.5)
Week 12 (n = 323, 315)	87.5 (84.0 to 91.0)	84.5 (80.6 to 88.5)
Week 16 (n = 320, 314)	90.6 (87.5 to 93.7)	76.5 (71.9 to 81.0)
Week 20 (n = 320, 305)	78.8 (74.5 to 83.0)	86.1 (82.3 to 89.8)
Week 24 (n = 294, 284)	78.7 (74.2 to 83.1)	78.0 (73.4 to 82.7)
Week 28 (n = 291, 273)	77.1 (72.4 to 81.8)	85.9 (81.8 to 89.9)
Week 32 (n = 286, 291)	86.3 (82.5 to 90.2)	78.3 (73.6 to 82.9)
Week 36 (n = 293, 278)	79.6 (75.0 to 84.1)	86.1 (82.1 to 90.1)
Week 40 (n = 277, 278)	84.5 (80.3 to 88.7)	77.5 (72.7 to 82.3)
Week 44 (n = 275, 258)	78.5 (73.7 to 83.2)	84.2 (79.9 to 88.5)
Week 48 (n = 274, 269)	84.1 (79.8 to 88.4)	77.7 (72.8 to 82.5)
Week 52 (n = 281, 270)	85.9 (81.9 to 89.8)	85.3 (81.1 to 89.4)
Week 56 (n = 281, 272)	85.2 (81.1 to 89.2)	81.1 (76.6 to 85.6)
Week 60 (n = 273, 266)	77.8 (73.0 to 82.6)	85.4 (81.2 to 89.5)
Week 104 (n = 259, 247)	86.0 (81.9 to 90.1)	80.0 (75.1 to 84.9)
Week 108 (n = 264, 243)	82.2 (77.7 to 86.6)	83.5 (79.0 to 88.1)
Week 112 (n = 266, 251)	85.9 (81.8 to 90.0)	80.5 (75.7 to 85.4)

Notes
[39] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[40] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye Over Time

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End point title

Percentage of Participants with Absence of Subretinal Fluid in the Study Eye Over Time

End point description

Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[41]	327 ^[42]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 319)	70.9 (66.1 to 75.7)	61.7 (56.4 to 66.9)
Week 8 (n = 323, 319)	79.8 (75.6 to 84.1)	73.6 (68.9 to 78.4)
Week 12 (n = 324, 315)	88.6 (85.1 to 92.0)	79.6 (75.3 to 84.0)
Week 16 (n = 320, 315)	90.6 (87.4 to 93.8)	63.8 (58.6 to 68.9)
Week 20 (n = 320, 308)	76.1 (71.6 to 80.7)	80.4 (76.1 to 84.8)
Week 24 (n = 295, 287)	73.7 (68.8 to 78.5)	59.1 (53.5 to 64.6)
Week 28 (n = 292, 272)	71.5 (66.6 to 76.4)	78.7 (73.9 to 83.5)
Week 32 (n = 287, 291)	82.6 (78.3 to 87.0)	62.2 (56.7 to 67.7)
Week 36 (n = 293, 282)	70.6 (65.5 to 75.7)	80.7 (76.1 to 85.2)
Week 40 (n = 283, 285)	77.6 (72.9 to 82.3)	63.9 (58.4 to 69.5)
Week 44 (n = 280, 269)	65.7 (60.3 to 71.0)	76.2 (71.1 to 81.2)
Week 48 (n = 278, 274)	72.5 (67.5 to 77.5)	62.1 (56.5 to 67.7)
Week 52 (n = 281, 271)	83.0 (78.8 to 87.3)	80.6 (76.0 to 85.3)
Week 56 (n = 282, 271)	80.7 (76.3 to 85.2)	71.6 (66.4 to 76.8)
Week 60 (n = 278, 271)	63.6 (58.1 to 69.0)	80.0 (75.3 to 84.8)
Week 104 (n = 262, 248)	80.0 (75.3 to 84.7)	73.9 (68.5 to 79.3)
Week 108 (n = 266, 244)	76.1 (71.2 to 81.0)	80.7 (75.8 to 85.5)
Week 112 (n = 267, 252)	80.9 (76.4 to 85.4)	77.5 (72.4 to 82.6)

Notes
[41] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[42] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time

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End point title

Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time

End point description

Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of intraretinal and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[43]	327 ^[44]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 324, 319)	59.5 (54.2 to 64.8)	49.8 (44.4 to 55.2)
Week 8 (n = 323, 315)	70.2 (65.2 to 75.1)	61.6 (56.3 to 66.9)
Week 12 (n = 323, 315)	77.0 (72.4 to 81.5)	66.6 (61.5 to 71.7)
Week 16 (n = 319, 315)	82.4 (78.3 to 86.5)	47.6 (42.2 to 53.0)
Week 20 (n = 320, 305)	62.3 (57.3 to 67.4)	68.6 (63.6 to 73.7)
Week 24 (n = 295, 284)	56.5 (50.8 to 62.1)	45.4 (39.7 to 51.1)
Week 28 (n = 291, 273)	55.5 (49.9 to 61.1)	66.5 (61.0 to 72.0)
Week 32 (n = 286, 291)	73.1 (68.0 to 78.1)	48.6 (42.9 to 54.3)
Week 36 (n = 293, 278)	56.3 (50.8 to 61.9)	68.3 (62.9 to 73.7)
Week 40 (n = 278, 281)	65.8 (60.3 to 71.2)	49.0 (43.2 to 54.8)
Week 44 (n = 277, 262)	49.5 (43.7 to 55.3)	64.3 (58.5 to 70.0)
Week 48 (n = 277, 270)	62.2 (56.6 to 67.8)	46.1 (40.3 to 52.0)
Week 52 (n = 281, 270)	70.3 (65.2 to 75.5)	68.8 (63.4 to 74.3)
Week 56 (n = 281, 272)	66.9 (61.5 to 72.3)	57.5 (51.8 to 63.3)
Week 60 (n = 275, 266)	49.3 (43.5 to 55.0)	69.1 (63.6 to 74.6)
Week 104 (n = 259, 247)	68.1 (62.5 to 73.7)	58.6 (52.7 to 64.6)
Week 108 (n = 264, 243)	61.6 (55.9 to 67.3)	67.1 (61.3 to 72.9)
Week 112 (n = 266, 251)	68.7 (63.3 to 74.1)	61.1 (55.1 to 67.1)

Notes
[43] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[44] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with Absence of Pigment Epithelial Detachment in the Study Eye Over Time

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End point title

Percentage of Participants with Absence of Pigment Epithelial Detachment in the Study Eye Over Time

End point description

Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331 ^[45]	327 ^[46]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 323, 320)	3.7 (1.7 to 5.8)	5.6 (3.1 to 8.1)
Week 8 (n = 321, 318)	3.1 (1.3 to 5.0)	4.1 (1.9 to 6.2)
Week 12 (n = 321, 314)	4.7 (2.4 to 7.0)	5.5 (3.0 to 8.0)
Week 16 (n = 316, 313)	2.5 (0.8 to 4.1)	5.8 (3.2 to 8.4)
Week 20 (n = 316, 306)	3.8 (1.7 to 5.9)	6.0 (3.4 to 8.6)
Week 24 (n = 293, 284)	4.1 (1.8 to 6.3)	4.9 (2.5 to 7.4)
Week 28 (n = 292, 273)	2.6 (0.9 to 4.4)	1.9 (0.3 to 3.5)
Week 32 (n = 287, 291)	4.3 (2.0 to 6.6)	1.8 (0.3 to 3.3)
Week 36 (n = 293, 283)	4.8 (2.4 to 7.1)	3.9 (1.7 to 6.1)
Week 40 (n = 284, 286)	6.3 (3.5 to 9.0)	7.3 (4.4 to 10.3)
Week 44 (n = 282, 270)	3.9 (1.7 to 6.2)	9.1 (5.9 to 12.4)
Week 48 (n = 280, 275)	3.3 (1.2 to 5.3)	6.5 (3.7 to 9.3)
Week 52 (n = 273, 267)	5.8 (3.1 to 8.5)	8.1 (5.0 to 11.3)
Week 56 (n = 272, 266)	4.7 (2.3 to 7.2)	5.2 (2.7 to 7.7)
Week 60 (n = 278, 271)	3.5 (1.4 to 5.6)	6.3 (3.4 to 9.1)
Week 104 (n = 260, 246)	8.0 (4.8 to 11.2)	8.3 (5.0 to 11.7)
Week 108 (n = 264, 244)	6.9 (3.9 to 10.0)	8.0 (4.7 to 11.2)
Week 112 (n = 264, 248)	8.1 (4.9 to 11.3)	12.5 (8.4 to 16.5)

Notes
[45] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.
[46] - The 'n' analyzed indicates subjects with a non-missing, valid assessment at a given timepoint.

No statistical analyses for this end point

Secondary: Percentage of Participants with Absence of Intraretinal Cysts in the Study Eye Over Time

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End point title

Percentage of Participants with Absence of Intraretinal Cysts in the Study Eye Over Time

End point description

End point type

Secondary

End point timeframe

Up to 112 weeks

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	0 ^[47]	0 ^[48]
Units: Percentage of participants
number (confidence interval 95%)	( to )	( to )

Notes
[47] - Not evaluated; absence of intraretinal (IR) fluid and IR cysts are described by the same variable.
[48] - Not evaluated; absence of intraretinal (IR) fluid and IR cysts are described by the same variable.

No statistical analyses for this end point

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

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End point title

Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

End point description

The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.

End point type

Secondary

End point timeframe

Baseline and Week 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	240	236
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	0.3 ± 4.6	1.1 ± 4.4

No statistical analyses for this end point

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112

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End point title

Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112

End point description

End point type

Secondary

End point timeframe

Baseline and Week 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	240	224
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	1.7 ± 7.5	1.7 ± 4.2

No statistical analyses for this end point

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48

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End point title

Change from Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48

End point description

The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.

End point type

Secondary

End point timeframe

Baseline and Week 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	241	238
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	-3.3 ± 6.6	-2.1 ± 6.3

No statistical analyses for this end point

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112

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End point title

Change from Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112

End point description

End point type

Secondary

End point timeframe

Baseline and Week 112

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	239	220
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	-5.3 ± 7.2	-4.2 ± 5.9

No statistical analyses for this end point

Secondary: Percentage of Participants with at Least One Adverse Event

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End point title

Percentage of Participants with at Least One Adverse Event

End point description

This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs and is conducted on the safety-evaluable population. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).

End point type

Secondary

End point timeframe

From first dose of study drug through end of study (up to 112 weeks)

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Percentage of participants
number (not applicable)
Adverse Event (AE)	84.9	88.0
Serious AE (SAE)	27.5	31.0
AE Leading to Withdrawal from Study Treatment	4.8	2.8
AE of Special Interest (AESI)	7.3	6.1

No statistical analyses for this end point

Secondary: Percentage of Participants with at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye

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End point title

Percentage of Participants with at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye

End point description

This analysis of adverse events (AEs) is conducted on the safety-evaluable population, which includes all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye. It only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).

End point type

Secondary

End point timeframe

From first dose of study drug through end of study (up to 112 weeks)

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Percentage of participants
number (not applicable)
Study Eye: Adverse Event (AE)	52.9	47.5
Study Eye: Serious AE (SAE)	4.5	4.9
Study Eye: AE Leading to Withdrawal from Treatment	3.3	1.8
Study Eye: Treatment-related AE	3.6	3.1
Study Eye: Treatment-related SAE	1.8	0.6
Study Eye: AE of Special Interest (AESI)	3.9	4.3
Study Eye: AESI, Drop in VA Score ≥30 Letters	2.7	3.1
Study Eye: AESI, Associated with Severe IOI	0.6	0.3
StudyEye:AESI,Interv Req to Avoid Perm Vision Loss	0.6	0.9
StudyEye:Suspected Transm Infectious Agent by Drug	0.0	0.3
Fellow Eye: AE	46.2	41.7
Fellow Eye: SAE	3.6	2.5
Fellow Eye: AESI	3.0	2.1
Fellow Eye: AESI, Drop in VA Score ≥30 Letters	2.1	1.8
FellowEye:AESI,Inter Req to Avoid Perm Vision Loss	0.9	0.3

No statistical analyses for this end point

Secondary: Percentage of Participants with at Least One Non-Ocular Adverse Event

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End point title

Percentage of Participants with at Least One Non-Ocular Adverse Event

End point description

This analysis of adverse events (AEs) is conducted on the safety-evaluable population, which includes all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye. It only includes non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

End point type

Secondary

End point timeframe

From first dose of study drug through end of study (up to 112 weeks)

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	331	326
Units: Percentage of participants
number (not applicable)
Adverse Event (AE)	71.0	75.8
Serious AE (SAE)	21.8	26.4
AE Leading to Withdrawal from Study Treatment	1.5	0.9
AE of Special Interest (AESI)	0.3	0.0

No statistical analyses for this end point

Secondary: Plasma Concentration of Faricimab Over Time

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End point title

Plasma Concentration of Faricimab Over Time ^[49]

End point description

Faricimab concentration in plasma was determined using a validated immunoassay method. This analysis only includes Arm A participants who received treatment with faricimab in the pharmacokinetic-evaluable population, which includes all safety-evaluable participants with at least one plasma sample, provided sufficient dosing information (dose and dosing time) was available. The number of participants analyzed at a given timepoint includes those with an available plasma sample and dosing information at that timepoint.

End point type

Secondary

End point timeframe

Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112

Notes
[49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants who were randomized to Arm A: Faricimab.

End point values	Arm A: Faricimab
Number of subjects analysed	331
Units: micrograms per millilitre (μg/mL)
arithmetic mean (standard deviation)
Baseline (n = 321)	0.0000 ± 0.0001
Week 4 (n = 319)	0.0287 ± 0.0209
Week 16 (n = 300)	0.0333 ± 0.0250
Week 20 (n = 305)	0.0046 ± 0.0051
Week 48 (n = 273)	0.0149 ± 0.0185
Week 76 (n = 269)	0.0053 ± 0.0117
Week 112 (n = 278)	0.0119 ± 0.0149

No statistical analyses for this end point

Secondary: Percentage of Participants who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study

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End point title

Percentage of Participants who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study ^[50]

End point description

Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. The immunogenicity-analysis population includes all participants randomized to the faricimab arm with at least one determinant ADA assessment. Only those with at least one post-baseline ADA assessment were included in this analysis.

End point type

Secondary

End point timeframe

Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112

Notes
[50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants who were randomized to Arm A: Faricimab.

End point values	Arm A: Faricimab
Number of subjects analysed	330
Units: Percentage of participants
number (not applicable)
Total Treatment-Emergent ADA-Positive	16.1
Treatment-Induced ADA-Positive	16.1
Treatment-Boosted ADA-Positive	0.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From first dose of study drug through end of study (up to 112 weeks)

Adverse event reporting additional description

Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Arm B: Aflibercept

Reporting group description

Reporting group title

Arm A: Faricimab

Reporting group description

Serious adverse events	Arm B: Aflibercept	Arm A: Faricimab
Total subjects affected by serious adverse events
subjects affected / exposed	101 / 326 (30.98%)	91 / 331 (27.49%)
number of deaths (all causes)	14	10
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	2 / 326 (0.61%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Extranodal marginal zone B-cell lymphoma (MALT type)
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	0 / 326 (0.00%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Lung cancer metastatic
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to liver
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sarcomatoid carcinoma
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcomatoid carcinoma of the lung
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic neoplasm
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer stage IV
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebral haemangioma
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	2 / 326 (0.61%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	2 / 326 (0.61%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Pain
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ill-defined disorder
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Asthenia
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	2 / 326 (0.61%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Prostatomegaly
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic disorder
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	2 / 326 (0.61%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	4 / 326 (1.23%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung perforation
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary artery thrombosis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	3 / 326 (0.92%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Psychiatric disorders
Mixed anxiety and depressive disorder
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device malfunction
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Intraocular pressure increased
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Facial bones fracture
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asbestosis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	3 / 326 (0.92%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hip fracture
subjects affected / exposed	1 / 326 (0.31%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	2 / 326 (0.61%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract operation complication
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Comminuted fracture
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Foot fracture
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyphaema
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract traumatic
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal anastomotic leak
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 326 (0.31%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	3 / 326 (0.92%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	3 / 326 (0.92%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 2	0 / 1
Cardiac failure congestive
subjects affected / exposed	6 / 326 (1.84%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 11	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	3 / 326 (0.92%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Dressler's syndrome
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paroxysmal atrioventricular block
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary artery occlusion
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Brain oedema
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cerebral haemorrhage
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	5 / 326 (1.53%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 326 (0.61%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postictal paralysis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	2 / 326 (0.61%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Seizure
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombotic cerebral infarction
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	2 / 326 (0.61%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Quadriplegia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 326 (0.61%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Angle closure glaucoma
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal oedema
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye allergy
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular degeneration
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neovascular age-related macular degeneration
subjects affected / exposed	4 / 326 (1.23%)	8 / 331 (2.42%)
occurrences causally related to treatment / all	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal pigment epithelial tear
subjects affected / exposed	0 / 326 (0.00%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	1 / 326 (0.31%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Uveitis
subjects affected / exposed	2 / 326 (0.61%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	1 / 2	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vitritis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-infectious endophthalmitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Age-related macular degeneration
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral exudative haemorrhagic chorioretinopathy
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dry age-related macular degeneration
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal opacity
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	3 / 326 (0.92%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	2 / 326 (0.61%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric dysplasia
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Biliary obstruction
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 326 (0.31%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Cystitis haemorrhagic
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal stiffness
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	2 / 326 (0.61%)	4 / 331 (1.21%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatic disorder
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	4 / 326 (1.23%)	3 / 331 (0.91%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	2 / 326 (0.61%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chorioretinitis
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	2 / 326 (0.61%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endophthalmitis
subjects affected / exposed	3 / 326 (0.92%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 326 (0.31%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	6 / 326 (1.84%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	5 / 326 (1.53%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral uveitis
subjects affected / exposed	0 / 326 (0.00%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	7 / 326 (2.15%)	2 / 331 (0.60%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Endocarditis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 326 (0.00%)	1 / 331 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vitamin B12 deficiency
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	1 / 326 (0.31%)	0 / 331 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Arm B: Aflibercept	Arm A: Faricimab
Total subjects affected by non serious adverse events
subjects affected / exposed	165 / 326 (50.61%)	178 / 331 (53.78%)
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	22 / 326 (6.75%)	18 / 331 (5.44%)
occurrences all number	27	20
Vascular disorders
Hypertension
subjects affected / exposed	18 / 326 (5.52%)	15 / 331 (4.53%)
occurrences all number	18	15
Eye disorders
Conjunctival haemorrhage
subjects affected / exposed	37 / 326 (11.35%)	35 / 331 (10.57%)
occurrences all number	72	47
Neovascular age-related macular degeneration
subjects affected / exposed	62 / 326 (19.02%)	80 / 331 (24.17%)
occurrences all number	81	103
Dry eye
subjects affected / exposed	21 / 326 (6.44%)	15 / 331 (4.53%)
occurrences all number	37	27
Cataract
subjects affected / exposed	26 / 326 (7.98%)	38 / 331 (11.48%)
occurrences all number	38	55
Vitreous detachment
subjects affected / exposed	21 / 326 (6.44%)	22 / 331 (6.65%)
occurrences all number	26	29
Posterior capsule opacification
subjects affected / exposed	19 / 326 (5.83%)	15 / 331 (4.53%)
occurrences all number	23	20
Infections and infestations
Nasopharyngitis
subjects affected / exposed	22 / 326 (6.75%)	27 / 331 (8.16%)
occurrences all number	25	33
Urinary tract infection
subjects affected / exposed	29 / 326 (8.90%)	19 / 331 (5.74%)
occurrences all number	36	23

More information

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Were there any global substantial amendments to the protocol? Yes

28 Feb 2019

Protocol Version 2: Amended to address feedback from the Voluntary Harmonisation Procedure. To enhance patient safety and to comply with health authority requests, patients with a known hypersensitivity to fluorescein were excluded. Also, the criterion for interruption and resuming study treatment after IOI was amended for clarity.

06 Aug 2019

Protocol Version 3: -The criteria for the extension of the drug-dosing interval during the PTI phase was changed from a qualitative assessment of the presence of fluid to a quantitative assessment of CST stability.; -The study-eye inclusion criteria were amended to include patients with extrafoveal CNV membranes with a subfoveal component, secondary to nAMD.; -To ensure appropriate patient representation, the Sponsor could elect to cap the recruitment of patients in certain baseline BCVA strata.; -Reporting of medication errors and associated AE was updated. Medication errors were no longer to be reported expeditiously (within 24 hours), unless they caused a SAE or AESI. -As applicable throughout the protocol, the term "free" was added before VEGF-A and Ang-2 to more accurately describe what the assays were measuring and to be consistent with the other sections of the protocol.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (LUCERNE)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Primary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Change from Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Change from Baseline in BCVA in the Study Eye Over Time

Secondary: Change from Baseline in BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥0 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥0 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥15 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥10 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Avoiding a Loss of ≥5 Letters from the Baseline BCVA in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants Gaining ≥15 Letters from the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112

Secondary: Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 48

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 48

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 60

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 60

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 108

Secondary: Number of Study Drug Injections Received in the Study Eye Through Week 108

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Over Time

Secondary: Change from Baseline in Central Subfield Thickness in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Pigment Epithelial Detachment in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Pigment Epithelial Detachment in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Cysts in the Study Eye Over Time

Secondary: Percentage of Participants with Absence of Intraretinal Cysts in the Study Eye Over Time

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

Secondary: Change from Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

Clinical Trial Results:
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (LUCERNE)