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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 (TENAYA)

Summary
EudraCT number	2018-002152-32
Trial protocol	DE HU GB PL ES NL IT
Global end of trial date	18 Jan 2022

Results information
Results version number	v1(current)
This version publication date	01 Feb 2023
First version publication date	01 Feb 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

GR40306

ISRCTN number

US NCT number

NCT03823287

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche, Ltd.

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4070

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

18 Jan 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

26 Oct 2020

Global end of trial reached?

Yes

Global end of trial date

18 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

19 Feb 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 34

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Hungary: 19

Country: Number of subjects enrolled

Israel: 30

Country: Number of subjects enrolled

Italy: 11

Country: Number of subjects enrolled

Japan: 52

Country: Number of subjects enrolled

Mexico: 3

Country: Number of subjects enrolled

Netherlands: 5

Country: Number of subjects enrolled

Poland: 48

Country: Number of subjects enrolled

Russian Federation: 19

Country: Number of subjects enrolled

Spain: 40

Country: Number of subjects enrolled

Switzerland: 3

Country: Number of subjects enrolled

Turkey: 10

Country: Number of subjects enrolled

United Kingdom: 59

Country: Number of subjects enrolled

United States: 332

Worldwide total number of subjects

671

EEA total number of subjects

129

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

491

85 years and over

116

Subject disposition

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Recruitment details

Screening details

A total of 989 patients were screened, 318 of whom failed screening most commonly due to not meeting inclusion criteria. A total of 671 treatment-naive patients with nAMD were randomized 1:1 into the study: 334 to the faricimab arm and 337 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	334	337
Received at Least One Dose of Study Drug	333	336
Completed up to Week 48	319	323
Completed	274	291
Not completed	60	46
Consent withdrawn by subject	25	17
Physician decision	5	2
Adverse event, non-fatal	6	8
Death	13	7
Not Specified	2	4
Lost to follow-up	7	8
Lack of efficacy	2	-

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	334	337	671
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)	34	30	64
From 65-84 years	253	238	491
85 years and over	47	69	116
Age Continuous
Units: Years
arithmetic mean (standard deviation)	75.9 ± 8.6	76.7 ± 8.8	-
Sex: Female, Male
Units: Participants
Female	191	211	402
Male	143	126	269
Race/Ethnicity, Customized
Units: Subjects
White	303	302	605
Asian	26	28	54
Black or African American	0	3	3
American Indian or Alaska Native	1	2	3
Multiple	1	0	1
Unknown	3	2	5
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	26	26	52
Not Hispanic or Latino	303	308	611
Unknown or Not Reported	5	3	8
Region of Enrollment
Units: Subjects
United States and Canada	182	184	366
Asia	26	26	52
Rest of the World	126	127	253
Number of Participants by the Eye (Right or Left) Chosen as the Study Eye
Units: Subjects
Right Eye	166	178	344
Left Eye	168	159	327
Number of Participants by the BCVA Letter Score Categories in the Study Eye
Units: Subjects
≥74 Letters	47	52	99
73 to 55 Letters	200	201	401
≤54 Letters	87	84	171
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye
Units: Subjects
<33 Letters	236	235	471
≥33 Letters	95	98	193
Missing/Invalid	3	4	7
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Units: Subjects
Occult	177	174	351
Classic	84	73	157
Minimally Classic	32	30	62
Retinal Angiomatous Proliferation (RAP)	14	27	41
Predominantly Classic	17	19	36
Polypoidal Choroidal Vasculopathy (PCV)	6	6	12
Missing	4	8	12
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)	61.3 ± 12.5	61.5 ± 12.9	-

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	334	337
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)	5.8 (4.6 to 7.1)	5.1 (3.9 to 6.4)

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

671

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

Adjusted mean difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

2.5

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	334	337
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)	5.4 (4.0 to 6.8)	4.6 (3.3 to 6.0)

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

671

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

0.99

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	334	337
Units: ETDRS Letters
arithmetic mean (confidence interval 95%)
Week 4	4.0 (3.2 to 4.8)	3.6 (2.8 to 4.4)
Week 8	5.5 (4.6 to 6.4)	4.5 (3.6 to 5.4)
Week 12	6.4 (5.5 to 7.4)	5.3 (4.4 to 6.2)
Week 16	6.8 (5.8 to 7.8)	5.2 (4.2 to 6.2)
Week 20	6.6 (5.5 to 7.6)	4.9 (3.9 to 6.0)
Week 24	6.4 (5.2 to 7.5)	5.1 (4.0 to 6.3)
Week 28	6.2 (5.1 to 7.3)	5.6 (4.5 to 6.7)
Week 32	6.2 (4.9 to 7.4)	5.1 (3.8 to 6.3)
Week 36	6.5 (5.3 to 7.7)	5.5 (4.3 to 6.7)
Week 40	6.1 (4.9 to 7.4)	5.1 (3.9 to 6.4)
Week 44	5.8 (4.5 to 7.1)	5.1 (3.8 to 6.4)
Week 48	5.5 (4.1 to 6.9)	5.2 (3.8 to 6.5)
Week 52	5.6 (4.2 to 7.1)	4.5 (3.1 to 5.9)
Week 56	5.5 (4.1 to 6.9)	4.7 (3.3 to 6.1)
Week 60	4.9 (3.5 to 6.3)	4.7 (3.2 to 6.1)
Week 64	5.5 (4.1 to 6.9)	4.8 (3.5 to 6.2)
Week 68	5.3 (3.9 to 6.8)	4.6 (3.2 to 6.1)
Week 72	4.8 (3.3 to 6.3)	4.0 (2.5 to 5.4)
Week 76	4.7 (3.1 to 6.2)	4.4 (2.9 to 5.9)
Week 80	4.6 (3.1 to 6.1)	3.5 (2.0 to 5.1)
Week 84	4.5 (3.0 to 6.1)	3.5 (2.0 to 5.1)
Week 88	4.3 (2.7 to 5.9)	3.7 (2.1 to 5.2)
Week 92	4.2 (2.6 to 5.9)	3.7 (2.1 to 5.3)
Week 96	4.2 (2.5 to 5.8)	3.7 (2.0 to 5.3)
Week 100	4.3 (2.7 to 5.9)	3.6 (2.0 to 5.2)
Week 104	4.1 (2.5 to 5.8)	3.6 (2.0 to 5.2)
Week 108	3.6 (1.8 to 5.3)	3.2 (1.5 to 4.9)
Week 112	3.5 (1.8 to 5.2)	3.1 (1.4 to 4.8)

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	292 ^[2]	300 ^[3]
Units: Percentage of participants
number (confidence interval 95%)
Gaining ≥15 Letters	20.0 (15.6 to 24.4)	15.7 (11.9 to 19.6)
Gaining ≥10 Letters	37.1 (31.7 to 42.4)	31.7 (26.7 to 36.8)
Gaining ≥5 Letters	59.2 (53.7 to 64.7)	58.0 (52.6 to 63.5)
Gaining ≥0 Letters	75.6 (70.8 to 80.3)	76.8 (72.1 to 81.4)

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

592

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

4.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

10.1

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

592

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

5.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

12.7

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

592

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

-6.6

upper limit

8.9

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

592

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

-7.9

upper limit

5.4

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	277 ^[4]	283 ^[5]
Units: Percentage of participants
number (confidence interval 95%)	19.2 (15.0 to 23.5)	16.6 (12.5 to 20.6)

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

560

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

8.5

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	334 ^[6]	337 ^[7]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	10.1 (6.9 to 13.2)	6.3 (3.8 to 8.8)
Week 8 (n = 325, 325)	13.7 (10.1 to 17.3)	8.1 (5.3 to 10.9)
Week 12 (n = 322, 326)	16.7 (12.8 to 20.5)	10.1 (7.0 to 13.1)
Week 16 (n = 322, 320)	17.7 (13.7 to 21.6)	13.4 (10.0 to 16.9)
Week 20 (n = 308, 308)	19.1 (14.9 to 23.2)	12.7 (9.1 to 16.2)
Week 24 (n = 278, 285)	22.1 (17.4 to 26.7)	13.3 (9.6 to 17.0)
Week 28 (n = 284, 276)	20.8 (16.4 to 25.2)	16.2 (12.1 to 20.3)
Week 32 (n = 293, 285)	21.6 (17.0 to 26.1)	15.1 (11.3 to 18.9)
Week 36 (n = 286, 297)	21.4 (16.8 to 26.0)	15.7 (11.8 to 19.6)
Week 40 (n = 287, 291)	22.1 (17.5 to 26.7)	15.6 (11.7 to 19.5)
Week 44 (n = 278, 274)	22.2 (17.5 to 26.8)	17.4 (13.2 to 21.6)
Week 48 (n = 273, 279)	21.2 (16.7 to 25.8)	19.7 (15.3 to 24.0)
Week 52 (n = 272, 278)	22.5 (17.8 to 27.2)	18.3 (14.0 to 22.7)
Week 56 (n = 273, 279)	23.1 (18.4 to 27.8)	18.8 (14.6 to 23.0)
Week 60 (n = 268, 276)	21.3 (16.7 to 25.9)	17.4 (13.3 to 21.5)
Week 64 (n = 253, 276)	20.3 (15.6 to 25.0)	20.1 (15.7 to 24.6)
Week 68 (n = 260, 269)	23.2 (18.3 to 28.1)	18.5 (14.1 to 22.8)
Week 72 (n = 262, 274)	21.1 (16.5 to 25.8)	17.4 (13.1 to 21.6)
Week 76 (n = 255, 260)	22.9 (18.0 to 27.8)	18.0 (13.7 to 22.3)
Week 80 (n = 254, 268)	19.7 (14.9 to 24.5)	18.8 (14.4 to 23.2)
Week 84 (n = 257, 270)	21.1 (16.4 to 25.9)	18.3 (14.0 to 22.5)
Week 88 (n = 256, 267)	24.6 (19.7 to 29.6)	18.6 (14.3 to 23.0)
Week 92 (n = 247, 266)	21.4 (16.5 to 26.3)	19.5 (14.9 to 24.0)
Week 96 (n = 249, 258)	23.0 (18.1 to 27.9)	20.2 (15.7 to 24.6)
Week 100 (n = 248, 258)	21.5 (16.7 to 26.3)	18.2 (13.9 to 22.5)
Week 104 (n = 250, 263)	22.9 (17.9 to 27.8)	18.6 (14.2 to 22.9)
Week 108 (n = 246, 256)	21.9 (17.0 to 26.7)	19.0 (14.6 to 23.4)
Week 112 (n = 247, 259)	24.0 (19.1 to 29.0)	19.2 (14.6 to 23.7)

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

Top of page

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	334 ^[8]	337 ^[9]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	20.1 (16.0 to 24.2)	16.0 (12.3 to 19.7)
Week 8 (n = 325, 325)	28.6 (23.9 to 33.3)	25.3 (20.9 to 29.8)
Week 12 (n = 322, 326)	31.4 (26.5 to 36.3)	30.3 (25.5 to 35.1)
Week 16 (n = 322, 320)	36.9 (31.8 to 41.9)	31.9 (27.0 to 36.7)
Week 20 (n = 308, 308)	39.1 (34.0 to 44.2)	30.3 (25.4 to 35.2)
Week 24 (n = 278, 285)	41.4 (36.0 to 46.9)	34.0 (28.7 to 39.3)
Week 28 (n = 284, 276)	38.9 (33.5 to 44.3)	34.8 (29.5 to 40.1)
Week 32 (n = 293, 285)	38.6 (33.2 to 44.0)	32.4 (27.2 to 37.7)
Week 36 (n = 286, 297)	37.1 (31.6 to 42.6)	34.0 (28.8 to 39.2)
Week 40 (n = 287, 291)	36.9 (31.5 to 42.3)	33.9 (28.6 to 39.2)
Week 44 (n = 278, 274)	39.5 (33.9 to 45.0)	34.3 (29.0 to 39.7)
Week 48 (n = 273, 279)	36.8 (31.3 to 42.3)	36.8 (31.4 to 42.2)
Week 52 (n = 272, 278)	38.7 (33.2 to 44.2)	37.7 (32.2 to 43.2)
Week 56 (n = 273, 279)	40.3 (34.8 to 45.8)	36.2 (30.8 to 41.6)
Week 60 (n = 268, 276)	40.1 (34.7 to 45.5)	34.8 (29.4 to 40.3)
Week 64 (n = 253, 276)	37.2 (31.4 to 43.0)	36.6 (31.1 to 42.0)
Week 68 (n = 260, 269)	40.0 (34.3 to 45.7)	33.3 (27.8 to 38.7)
Week 72 (n = 262, 274)	40.1 (34.4 to 45.8)	34.3 (28.8 to 39.8)
Week 76 (n = 255, 260)	39.4 (33.7 to 45.2)	33.5 (28.0 to 39.0)
Week 80 (n = 254, 268)	35.5 (29.8 to 41.2)	33.0 (27.7 to 38.4)
Week 84 (n = 257, 270)	38.2 (32.5 to 43.9)	34.3 (28.9 to 39.7)
Week 88 (n = 256, 267)	38.9 (33.2 to 44.7)	33.6 (28.3 to 39.0)
Week 92 (n = 247, 266)	37.8 (31.9 to 43.7)	35.3 (29.7 to 40.8)
Week 96 (n = 249, 258)	39.6 (33.7 to 45.4)	35.8 (30.3 to 41.4)
Week 100 (n = 248, 258)	38.5 (32.7 to 44.4)	36.4 (30.8 to 42.0)
Week 104 (n = 250, 263)	38.7 (32.9 to 44.6)	38.9 (33.3 to 44.5)
Week 108 (n = 246, 256)	35.1 (29.3 to 40.9)	36.6 (30.9 to 42.2)
Week 112 (n = 247, 259)	39.5 (33.8 to 45.3)	34.9 (29.3 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	334 ^[10]	337 ^[11]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	47.6 (42.3 to 52.8)	45.6 (40.4 to 50.9)
Week 8 (n = 325, 325)	57.8 (52.5 to 63.0)	52.3 (47.2 to 57.5)
Week 12 (n = 322, 326)	61.5 (56.3 to 66.8)	55.0 (49.7 to 60.2)
Week 16 (n = 322, 320)	61.8 (56.5 to 67.0)	54.0 (48.7 to 59.3)
Week 20 (n = 308, 308)	60.2 (54.8 to 65.6)	55.5 (50.0 to 60.9)
Week 24 (n = 278, 285)	63.4 (57.9 to 68.9)	53.6 (48.0 to 59.3)
Week 28 (n = 284, 276)	60.8 (55.3 to 66.3)	61.4 (55.8 to 67.0)
Week 32 (n = 293, 285)	60.5 (55.1 to 65.9)	56.4 (50.8 to 62.0)
Week 36 (n = 286, 297)	60.5 (55.0 to 66.0)	58.5 (53.0 to 64.0)
Week 40 (n = 287, 291)	59.1 (53.6 to 64.6)	54.5 (48.9 to 60.2)
Week 44 (n = 278, 274)	60.3 (54.7 to 65.9)	59.0 (53.3 to 64.6)
Week 48 (n = 273, 279)	59.3 (53.7 to 65.0)	58.8 (53.2 to 64.4)
Week 52 (n = 272, 278)	62.6 (57.0 to 68.1)	58.5 (52.8 to 64.1)
Week 56 (n = 273, 279)	58.6 (53.0 to 64.2)	54.4 (48.7 to 60.2)
Week 60 (n = 268, 276)	60.4 (54.8 to 66.0)	57.4 (51.6 to 63.1)
Week 64 (n = 253, 276)	59.3 (53.5 to 65.2)	55.1 (49.3 to 60.9)
Week 68 (n = 260, 269)	60.4 (54.7 to 66.1)	57.0 (51.2 to 62.7)
Week 72 (n = 262, 274)	59.8 (54.0 to 65.5)	52.3 (46.5 to 58.1)
Week 76 (n = 255, 260)	59.3 (53.5 to 65.1)	55.0 (49.1 to 60.9)
Week 80 (n = 254, 268)	55.2 (49.3 to 61.2)	55.5 (49.6 to 61.3)
Week 84 (n = 257, 270)	58.4 (52.6 to 64.2)	55.6 (49.8 to 61.4)
Week 88 (n = 256, 267)	59.3 (53.5 to 65.1)	53.8 (48.0 to 59.6)
Week 92 (n = 247, 266)	56.8 (50.8 to 62.9)	56.0 (50.3 to 61.8)
Week 96 (n = 249, 258)	58.2 (52.2 to 64.1)	57.5 (51.7 to 63.4)
Week 100 (n = 248, 258)	59.1 (53.2 to 65.1)	57.1 (51.2 to 63.0)
Week 104 (n = 250, 263)	59.8 (54.0 to 65.7)	54.8 (48.9 to 60.7)
Week 108 (n = 246, 256)	53.6 (47.7 to 59.6)	54.1 (48.2 to 60.1)
Week 112 (n = 247, 259)	57.3 (51.4 to 63.2)	53.5 (47.6 to 59.5)

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	334 ^[12]	337 ^[13]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	78.9 (74.5 to 83.2)	77.6 (73.3 to 81.9)
Week 8 (n = 325, 325)	80.7 (76.4 to 84.9)	78.3 (73.9 to 82.7)
Week 12 (n = 322, 326)	84.2 (80.3 to 88.1)	81.4 (77.3 to 85.6)
Week 16 (n = 322, 320)	84.8 (80.9 to 88.7)	78.8 (74.6 to 83.1)
Week 20 (n = 308, 308)	80.8 (76.5 to 85.2)	79.6 (75.2 to 83.9)
Week 24 (n = 278, 285)	81.9 (77.5 to 86.3)	79.6 (75.1 to 84.1)
Week 28 (n = 284, 276)	77.8 (73.1 to 82.6)	82.3 (77.9 to 86.7)
Week 32 (n = 293, 285)	78.7 (74.2 to 83.1)	76.3 (71.5 to 81.0)
Week 36 (n = 286, 297)	78.9 (74.3 to 83.5)	81.0 (76.6 to 85.4)
Week 40 (n = 287, 291)	77.1 (72.5 to 81.7)	80.7 (76.3 to 85.2)
Week 44 (n = 278, 274)	77.0 (72.3 to 81.7)	78.3 (73.6 to 83.0)
Week 48 (n = 273, 279)	77.0 (72.2 to 81.8)	76.4 (71.5 to 81.3)
Week 52 (n = 272, 278)	77.4 (72.6 to 82.2)	75.7 (70.7 to 80.6)
Week 56 (n = 273, 279)	76.3 (71.4 to 81.1)	78.7 (73.9 to 83.5)
Week 60 (n = 268, 276)	74.4 (69.3 to 79.5)	77.5 (72.6 to 82.3)
Week 64 (n = 253, 276)	77.7 (72.8 to 82.6)	73.7 (68.6 to 78.8)
Week 68 (n = 260, 269)	74.9 (69.8 to 80.0)	77.7 (72.8 to 82.6)
Week 72 (n = 262, 274)	74.9 (69.9 to 79.8)	74.8 (69.8 to 79.8)
Week 76 (n = 255, 260)	75.7 (70.8 to 80.7)	72.0 (66.6 to 77.4)
Week 80 (n = 254, 268)	75.5 (70.4 to 80.5)	74.4 (69.3 to 79.5)
Week 84 (n = 257, 270)	75.5 (70.5 to 80.5)	72.5 (67.3 to 77.7)
Week 88 (n = 256, 267)	74.8 (69.6 to 80.0)	71.7 (66.4 to 76.9)
Week 92 (n = 247, 266)	75.0 (69.9 to 80.2)	70.6 (65.3 to 75.9)
Week 96 (n = 249, 258)	74.7 (69.6 to 79.9)	71.1 (65.7 to 76.5)
Week 100 (n = 248, 258)	74.6 (69.4 to 79.8)	69.7 (64.2 to 75.2)
Week 104 (n = 250, 263)	73.8 (68.6 to 79.1)	71.2 (66.0 to 76.5)
Week 108 (n = 246, 256)	73.4 (68.2 to 78.7)	73.7 (68.4 to 79.0)
Week 112 (n = 247, 259)	72.8 (67.5 to 78.1)	70.9 (65.5 to 76.3)

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	292 ^[14]	300 ^[15]
Units: Percentage of participants
number (confidence interval 95%)
Avoiding a Loss of ≥15 Letters	95.4 (93.0 to 97.7)	94.1 (91.5 to 96.7)
Avoiding a Loss of ≥10 Letters	91.6 (88.6 to 94.7)	92.0 (89.1 to 95.0)
Avoiding a Loss of ≥5 Letters	88.0 (84.3 to 91.6)	86.8 (83.0 to 90.5)

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

592

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

4.8

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

592

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

-4

upper limit

6.4

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

592

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

-4.6

upper limit

3.9

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	277 ^[16]	283 ^[17]
Units: Percentage of participants
number (confidence interval 95%)	93.9 (91.3 to 96.5)	94.1 (91.4 to 96.8)

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

560

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

3.6

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	334 ^[18]	337 ^[19]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	97.6 (95.9 to 99.2)	99.0 (98.0 to 100.0)
Week 8 (n = 325, 325)	97.6 (96.0 to 99.2)	98.7 (97.6 to 99.9)
Week 12 (n = 322, 326)	98.2 (96.7 to 99.6)	97.5 (95.8 to 99.1)
Week 16 (n = 322, 320)	98.1 (96.7 to 99.6)	97.0 (95.3 to 98.8)
Week 20 (n = 308, 308)	97.4 (95.7 to 99.1)	94.9 (92.5 to 97.3)
Week 24 (n = 278, 285)	97.2 (95.3 to 99.1)	97.5 (95.8 to 99.3)
Week 28 (n = 284, 276)	95.9 (93.8 to 98.1)	96.7 (94.6 to 98.8)
Week 32 (n = 293, 285)	95.4 (93.1 to 97.7)	95.7 (93.5 to 98.0)
Week 36 (n = 286, 297)	95.2 (92.8 to 97.6)	95.4 (93.1 to 97.7)
Week 40 (n = 287, 291)	96.6 (94.5 to 98.6)	94.2 (91.6 to 96.8)
Week 44 (n = 278, 274)	95.7 (93.5 to 98.0)	93.9 (91.2 to 96.6)
Week 48 (n = 273, 279)	94.0 (91.3 to 96.7)	93.3 (90.4 to 96.1)
Week 52 (n = 272, 278)	93.5 (90.8 to 96.2)	93.5 (90.7 to 96.3)
Week 56 (n = 273, 279)	94.7 (92.2 to 97.2)	95.0 (92.5 to 97.5)
Week 60 (n = 268, 276)	93.6 (90.8 to 96.4)	92.6 (89.7 to 95.6)
Week 64 (n = 253, 276)	94.1 (91.3 to 96.9)	92.9 (89.9 to 95.9)
Week 68 (n = 260, 269)	92.6 (89.6 to 95.6)	92.9 (89.9 to 95.8)
Week 72 (n = 262, 274)	93.5 (90.7 to 96.3)	91.3 (88.2 to 94.4)
Week 76 (n = 255, 260)	94.2 (91.6 to 96.8)	92.7 (89.8 to 95.7)
Week 80 (n = 254, 268)	93.6 (90.9 to 96.4)	90.7 (87.4 to 93.9)
Week 84 (n = 257, 270)	92.8 (89.9 to 95.7)	91.5 (88.4 to 94.5)
Week 88 (n = 256, 267)	93.1 (90.3 to 96.0)	90.4 (87.2 to 93.7)
Week 92 (n = 247, 266)	92.1 (89.1 to 95.2)	93.2 (90.5 to 95.9)
Week 96 (n = 249, 258)	91.6 (88.4 to 94.8)	88.9 (85.3 to 92.5)
Week 100 (n = 248, 258)	92.7 (89.8 to 95.6)	89.5 (86.0 to 93.0)
Week 104 (n = 250, 263)	93.2 (90.3 to 96.1)	90.7 (87.4 to 93.9)
Week 108 (n = 246, 256)	92.0 (88.9 to 95.1)	89.6 (86.0 to 93.2)
Week 112 (n = 247, 259)	90.6 (87.3 to 93.9)	88.8 (85.1 to 92.4)

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	334 ^[20]	337 ^[21]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	95.1 (92.9 to 97.4)	96.2 (94.3 to 98.2)
Week 8 (n = 325, 325)	96.0 (94.0 to 98.0)	96.9 (95.1 to 98.7)
Week 12 (n = 322, 326)	96.3 (94.4 to 98.3)	95.5 (93.3 to 97.7)
Week 16 (n = 322, 320)	95.1 (92.8 to 97.4)	92.6 (89.9 to 95.4)
Week 20 (n = 308, 308)	93.9 (91.3 to 96.5)	92.7 (89.9 to 95.4)
Week 24 (n = 278, 285)	94.3 (91.7 to 96.9)	94.4 (91.9 to 96.9)
Week 28 (n = 284, 276)	93.5 (90.8 to 96.2)	94.9 (92.3 to 97.4)
Week 32 (n = 293, 285)	92.5 (89.6 to 95.3)	92.9 (89.9 to 95.8)
Week 36 (n = 286, 297)	93.2 (90.3 to 96.0)	91.7 (88.6 to 94.7)
Week 40 (n = 287, 291)	92.2 (89.2 to 95.2)	91.8 (88.8 to 94.8)
Week 44 (n = 278, 274)	92.3 (89.4 to 95.3)	90.9 (87.7 to 94.2)
Week 48 (n = 273, 279)	91.5 (88.3 to 94.6)	91.5 (88.3 to 94.7)
Week 52 (n = 272, 278)	91.7 (88.6 to 94.7)	91.1 (87.8 to 94.4)
Week 56 (n = 273, 279)	92.3 (89.3 to 95.3)	90.4 (87.0 to 93.8)
Week 60 (n = 268, 276)	90.7 (87.5 to 94.0)	88.5 (85.0 to 92.1)
Week 64 (n = 253, 276)	91.3 (88.0 to 94.6)	90.3 (87.0 to 93.7)
Week 68 (n = 260, 269)	92.2 (89.2 to 95.3)	90.3 (86.9 to 93.7)
Week 72 (n = 262, 274)	89.6 (86.2 to 93.1)	88.1 (84.6 to 91.7)
Week 76 (n = 255, 260)	89.2 (85.6 to 92.7)	88.0 (84.3 to 91.8)
Week 80 (n = 254, 268)	89.3 (85.7 to 92.9)	86.4 (82.6 to 90.2)
Week 84 (n = 257, 270)	89.0 (85.5 to 92.5)	86.9 (83.2 to 90.7)
Week 88 (n = 256, 267)	89.2 (85.7 to 92.7)	85.2 (81.2 to 89.3)
Week 92 (n = 247, 266)	87.7 (83.8 to 91.6)	86.3 (82.4 to 90.1)
Week 96 (n = 249, 258)	87.8 (84.0 to 91.5)	85.7 (81.6 to 89.8)
Week 100 (n = 248, 258)	88.6 (84.9 to 92.3)	86.1 (82.1 to 90.1)
Week 104 (n = 250, 263)	87.6 (83.7 to 91.5)	85.3 (81.3 to 89.4)
Week 108 (n = 246, 256)	85.2 (81.1 to 89.4)	87.3 (83.4 to 91.2)
Week 112 (n = 247, 259)	84.7 (80.5 to 88.9)	84.2 (79.9 to 88.5)

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	334 ^[22]	337 ^[23]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	90.5 (87.4 to 93.6)	90.6 (87.5 to 93.6)
Week 8 (n = 325, 325)	92.3 (89.6 to 95.1)	90.6 (87.5 to 93.7)
Week 12 (n = 322, 326)	92.2 (89.4 to 95.1)	88.8 (85.4 to 92.1)
Week 16 (n = 322, 320)	90.4 (87.3 to 93.6)	87.4 (83.8 to 90.9)
Week 20 (n = 308, 308)	89.3 (85.9 to 92.7)	87.1 (83.5 to 90.7)
Week 24 (n = 278, 285)	89.1 (85.6 to 92.6)	88.8 (85.3 to 92.3)
Week 28 (n = 284, 276)	88.2 (84.6 to 91.9)	90.2 (86.7 to 93.6)
Week 32 (n = 293, 285)	87.0 (83.3 to 90.7)	85.8 (81.9 to 89.6)
Week 36 (n = 286, 297)	88.3 (84.7 to 91.9)	86.7 (82.9 to 90.4)
Week 40 (n = 287, 291)	86.8 (83.1 to 90.6)	87.4 (83.7 to 91.1)
Week 44 (n = 278, 274)	85.2 (81.3 to 89.2)	85.3 (81.2 to 89.4)
Week 48 (n = 273, 279)	85.6 (81.6 to 89.6)	83.5 (79.3 to 87.7)
Week 52 (n = 272, 278)	84.8 (80.7 to 88.9)	85.5 (81.4 to 89.6)
Week 56 (n = 273, 279)	84.4 (80.4 to 88.5)	83.7 (79.4 to 88.0)
Week 60 (n = 268, 276)	81.5 (77.0 to 85.9)	84.5 (80.4 to 88.6)
Week 64 (n = 253, 276)	87.8 (84.0 to 91.7)	85.3 (81.3 to 89.4)
Week 68 (n = 260, 269)	85.0 (80.9 to 89.1)	87.0 (83.1 to 90.9)
Week 72 (n = 262, 274)	84.2 (80.0 to 88.3)	81.1 (76.6 to 85.6)
Week 76 (n = 255, 260)	83.5 (79.1 to 87.8)	83.3 (78.9 to 87.7)
Week 80 (n = 254, 268)	81.0 (76.3 to 85.6)	81.9 (77.5 to 86.4)
Week 84 (n = 257, 270)	82.6 (78.2 to 86.9)	81.8 (77.4 to 86.3)
Week 88 (n = 256, 267)	80.8 (76.2 to 85.4)	78.8 (74.1 to 83.6)
Week 92 (n = 247, 266)	81.7 (77.1 to 86.3)	79.2 (74.5 to 83.9)
Week 96 (n = 249, 258)	82.1 (77.6 to 86.6)	78.1 (73.2 to 83.0)
Week 100 (n = 248, 258)	81.7 (77.1 to 86.3)	80.1 (75.4 to 84.8)
Week 104 (n = 250, 263)	79.6 (74.7 to 84.4)	80.5 (75.8 to 85.1)
Week 108 (n = 246, 256)	79.7 (74.9 to 84.4)	80.7 (75.9 to 85.4)
Week 112 (n = 247, 259)	78.6 (73.7 to 83.4)	78.9 (74.1 to 83.7)

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	292 ^[24]	300 ^[25]
Units: Percentage of participants
number (confidence interval 95%)	24.3 (19.5 to 29.1)	21.3 (16.8 to 25.7)

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

592

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

-3.6

upper limit

9.5

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	334 ^[26]	337 ^[27]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	11.0 (7.7 to 14.3)	8.1 (5.3 to 10.9)
Week 8 (n = 325, 325)	16.3 (12.3 to 20.2)	11.1 (7.8 to 14.4)
Week 12 (n = 322, 326)	20.4 (16.2 to 24.7)	14.9 (11.2 to 18.6)
Week 16 (n = 322, 320)	20.5 (16.3 to 24.8)	17.3 (13.4 to 21.3)
Week 20 (n = 308, 308)	22.4 (17.9 to 26.9)	17.7 (13.5 to 21.8)
Week 24 (n = 278, 285)	25.5 (20.5 to 30.5)	19.1 (14.7 to 23.4)
Week 28 (n = 284, 276)	25.7 (20.8 to 30.5)	20.0 (15.5 to 24.5)
Week 32 (n = 293, 285)	27.3 (22.4 to 32.3)	21.9 (17.3 to 26.5)
Week 36 (n = 286, 297)	27.2 (22.1 to 32.2)	23.7 (19.0 to 28.4)
Week 40 (n = 287, 291)	26.0 (21.0 to 30.9)	21.4 (16.8 to 25.9)
Week 44 (n = 278, 274)	26.5 (21.5 to 31.6)	22.8 (18.1 to 27.5)
Week 48 (n = 273, 279)	24.9 (20.0 to 29.8)	27.6 (22.5 to 32.6)
Week 52 (n = 272, 278)	25.0 (20.1 to 30.0)	23.8 (19.0 to 28.7)
Week 56 (n = 273, 279)	26.4 (21.4 to 31.5)	24.4 (19.7 to 29.1)
Week 60 (n = 268, 276)	25.2 (20.2 to 30.2)	22.7 (18.1 to 27.4)
Week 64 (n = 253, 276)	24.2 (19.1 to 29.3)	25.6 (20.6 to 30.5)
Week 68 (n = 260, 269)	27.5 (22.2 to 32.8)	24.3 (19.4 to 29.2)
Week 72 (n = 262, 274)	26.1 (21.0 to 31.2)	24.2 (19.4 to 29.0)
Week 76 (n = 255, 260)	27.6 (22.2 to 32.9)	23.6 (18.8 to 28.5)
Week 80 (n = 254, 268)	24.1 (18.9 to 29.3)	25.9 (20.9 to 31.0)
Week 84 (n = 257, 270)	26.2 (21.0 to 31.4)	23.8 (19.0 to 28.7)
Week 88 (n = 256, 267)	29.4 (24.0 to 34.7)	25.0 (19.9 to 30.0)
Week 92 (n = 247, 266)	27.7 (22.2 to 33.1)	27.3 (22.1 to 32.6)
Week 96 (n = 249, 258)	28.0 (22.6 to 33.3)	26.7 (21.7 to 31.8)
Week 100 (n = 248, 258)	27.3 (22.0 to 32.7)	24.4 (19.5 to 29.3)
Week 104 (n = 250, 263)	27.9 (22.5 to 33.3)	23.9 (18.9 to 28.8)
Week 108 (n = 246, 256)	27.3 (21.9 to 32.6)	24.2 (19.3 to 29.1)
Week 112 (n = 247, 259)	26.9 (21.6 to 32.1)	25.5 (20.4 to 30.6)

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	292 ^[28]	300 ^[29]
Units: Percentage of participants
number (confidence interval 95%)	56.4 (51.5 to 61.4)	57.0 (51.9 to 62.1)

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

592

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-7.7

upper limit

6.6

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	334 ^[30]	337 ^[31]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	52.8 (48.4 to 57.2)	50.5 (46.4 to 54.7)
Week 8 (n = 325, 325)	54.5 (49.9 to 59.1)	50.7 (46.3 to 55.1)
Week 12 (n = 322, 326)	58.3 (53.7 to 62.9)	53.4 (48.8 to 58.0)
Week 16 (n = 322, 320)	60.4 (55.6 to 65.2)	53.7 (49.1 to 58.3)
Week 20 (n = 308, 308)	59.5 (54.6 to 64.5)	54.4 (49.6 to 59.1)
Week 24 (n = 278, 285)	59.4 (54.3 to 64.5)	54.4 (49.4 to 59.4)
Week 28 (n = 284, 276)	57.5 (52.4 to 62.6)	59.0 (53.8 to 64.1)
Week 32 (n = 293, 285)	57.7 (52.7 to 62.8)	58.0 (52.8 to 63.1)
Week 36 (n = 286, 297)	59.7 (54.8 to 64.7)	59.6 (54.5 to 64.7)
Week 40 (n = 287, 291)	57.5 (52.4 to 62.7)	58.0 (52.8 to 63.1)
Week 44 (n = 278, 274)	59.9 (54.8 to 65.0)	59.4 (54.1 to 64.7)
Week 48 (n = 273, 279)	58.9 (53.7 to 64.1)	58.1 (52.7 to 63.6)
Week 52 (n = 272, 278)	61.0 (55.8 to 66.1)	57.4 (52.0 to 62.9)
Week 56 (n = 273, 279)	59.0 (53.8 to 64.2)	55.9 (50.5 to 61.3)
Week 60 (n = 268, 276)	57.9 (52.4 to 63.4)	56.8 (51.4 to 62.2)
Week 64 (n = 253, 276)	62.5 (57.1 to 67.9)	57.7 (52.3 to 63.0)
Week 68 (n = 260, 269)	61.0 (55.6 to 66.4)	59.3 (54.0 to 64.6)
Week 72 (n = 262, 274)	59.5 (54.0 to 65.0)	57.3 (52.0 to 62.6)
Week 76 (n = 255, 260)	58.4 (52.9 to 63.9)	55.3 (49.9 to 60.6)
Week 80 (n = 254, 268)	56.8 (51.2 to 62.4)	55.5 (50.1 to 60.9)
Week 84 (n = 257, 270)	57.6 (52.1 to 63.1)	58.0 (52.6 to 63.3)
Week 88 (n = 256, 267)	59.1 (53.5 to 64.8)	54.1 (48.5 to 59.7)
Week 92 (n = 247, 266)	58.6 (52.9 to 64.2)	57.8 (52.3 to 63.2)
Week 96 (n = 249, 258)	59.3 (53.7 to 64.9)	58.3 (52.6 to 64.0)
Week 100 (n = 248, 258)	58.1 (52.5 to 63.8)	57.4 (51.9 to 63.0)
Week 104 (n = 250, 263)	59.8 (54.2 to 65.5)	58.0 (52.4 to 63.6)
Week 108 (n = 246, 256)	56.4 (50.7 to 62.1)	56.4 (50.9 to 62.0)
Week 112 (n = 247, 259)	56.3 (50.4 to 62.2)	54.3 (48.6 to 59.9)

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

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 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	292 ^[32]	300 ^[33]
Units: Percentage of participants
number (confidence interval 95%)	6.4 (3.7 to 9.1)	6.9 (4.2 to 9.5)

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

592

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Difference in CMH Weighted Percentage

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

3.3

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	334 ^[34]	337 ^[35]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 327, 331)	5.5 (3.2 to 7.9)	5.5 (3.2 to 7.7)
Week 8 (n = 325, 325)	5.8 (3.4 to 8.3)	5.9 (3.6 to 8.2)
Week 12 (n = 322, 326)	4.6 (2.5 to 6.8)	5.6 (3.3 to 7.9)
Week 16 (n = 322, 320)	5.8 (3.5 to 8.2)	6.3 (3.9 to 8.8)
Week 20 (n = 308, 308)	5.9 (3.5 to 8.4)	6.9 (4.3 to 9.5)
Week 24 (n = 278, 285)	4.3 (2.0 to 6.6)	5.9 (3.4 to 8.5)
Week 28 (n = 284, 276)	5.4 (3.0 to 7.9)	5.2 (2.8 to 7.7)
Week 32 (n = 293, 285)	6.1 (3.5 to 8.7)	6.8 (4.2 to 9.4)
Week 36 (n = 286, 297)	6.4 (3.7 to 9.1)	6.7 (4.1 to 9.3)
Week 40 (n = 287, 291)	7.1 (4.3 to 9.9)	8.1 (5.3 to 11.0)
Week 44 (n = 278, 274)	7.0 (4.1 to 9.9)	6.7 (4.0 to 9.3)
Week 48 (n = 273, 279)	7.4 (4.4 to 10.4)	7.8 (4.9 to 10.7)
Week 52 (n = 272, 278)	8.1 (5.0 to 11.1)	9.4 (6.3 to 12.6)
Week 56 (n = 273, 279)	6.3 (3.6 to 9.0)	7.6 (4.7 to 10.5)
Week 60 (n = 268, 276)	6.9 (4.0 to 9.8)	8.7 (5.6 to 11.7)
Week 64 (n = 253, 276)	7.8 (4.6 to 11.0)	9.1 (6.0 to 12.3)
Week 68 (n = 260, 269)	7.6 (4.5 to 10.7)	9.3 (6.2 to 12.5)
Week 72 (n = 262, 274)	8.6 (5.4 to 11.8)	10.7 (7.5 to 13.9)
Week 76 (n = 255, 260)	7.9 (4.7 to 11.1)	10.8 (7.5 to 14.2)
Week 80 (n = 254, 268)	8.8 (5.5 to 12.0)	10.6 (7.2 to 13.9)
Week 84 (n = 257, 270)	7.7 (4.6 to 10.8)	11.0 (7.8 to 14.2)
Week 88 (n = 256, 267)	9.5 (6.1 to 12.9)	11.7 (8.3 to 15.0)
Week 92 (n = 247, 266)	9.0 (5.6 to 12.5)	12.4 (9.0 to 15.7)
Week 96 (n = 249, 258)	8.6 (5.3 to 12.0)	11.7 (8.2 to 15.1)
Week 100 (n = 248, 258)	8.3 (5.0 to 11.5)	11.9 (8.4 to 15.4)
Week 104 (n = 250, 263)	9.4 (6.0 to 12.9)	11.7 (8.3 to 15.1)
Week 108 (n = 246, 256)	7.7 (4.5 to 10.9)	10.4 (7.1 to 13.7)
Week 112 (n = 247, 259)	8.2 (4.9 to 11.5)	11.8 (8.3 to 15.2)

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	315
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	20.3 (15.9 to 24.8)
Once Every 12 Weeks	34.0 (28.7 to 39.2)
Once Every 16 Weeks	45.7 (40.2 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 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	302
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	20.2 (15.7 to 24.7)
Once Every 12 Weeks	33.4 (28.1 to 38.8)
Once Every 16 Weeks	46.4 (40.7 to 52.0)

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	271
Units: Percentage of participants
number (confidence interval 95%)
Once Every 8 Weeks	25.8 (20.6 to 31.0)
Once Every 12 Weeks	15.1 (10.9 to 19.4)
Once Every 16 Weeks	59.0 (53.2 to 64.9)

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	333	336
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	333	336
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	333	336
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 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 48

End point values	Arm A: Faricimab	Arm B: Aflibercept
Number of subjects analysed	334	337
Units: microns
arithmetic mean (confidence interval 95%)	-136.8 (-142.6 to -131.0)	-129.4 (-135.2 to -123.5)

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

671

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

-7.4

Confidence interval

level

95%

sides

2-sided

lower limit

-15.7

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

4.19

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

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	334	337
Units: microns
arithmetic mean (confidence interval 95%)	-134.5 (-140.5 to -128.6)	-135.5 (-141.5 to -129.6)

Treatment Difference at Weeks 52-60

Statistical analysis description

Comparison groups

Arm A: Faricimab v Arm B: Aflibercept

Number of subjects included in analysis

671

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Adjusted mean difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-7.4

upper limit

9.4

Variability estimate

Standard error of the mean

Dispersion value

4.26

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

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	334	337
Units: microns
arithmetic mean (confidence interval 95%)
Week 4	-131.7 (-137.9 to -125.4)	-116.3 (-122.5 to -110.1)
Week 8	-142.6 (-148.1 to -137.2)	-131.8 (-137.2 to -126.3)
Week 12	-149.0 (-154.1 to -143.9)	-136.1 (-141.2 to -131.1)
Week 16	-148.7 (-155.1 to -142.3)	-110.4 (-116.8 to -104.0)
Week 20	-132.9 (-139.2 to -126.6)	-136.1 (-142.4 to -129.8)
Week 24	-128.8 (-135.9 to -121.8)	-115.5 (-122.6 to -108.5)
Week 28	-129.1 (-135.5 to -122.8)	-132.5 (-139.0 to -126.1)
Week 32	-142.7 (-150.2 to -135.2)	-114.5 (-122.0 to -107.0)
Week 36	-132.8 (-138.9 to -126.7)	-139.1 (-145.2 to -133.1)
Week 40	-140.8 (-148.0 to -133.7)	-123.9 (-131.0 to -116.7)
Week 44	-133.9 (-139.9 to -128.0)	-142.4 (-148.3 to -136.4)
Week 48	-138.1 (-145.1 to -131.2)	-126.0 (-132.9 to -119.1)
Week 52	-139.9 (-146.2 to -133.6)	-139.6 (-145.9 to -133.3)
Week 56	-140.4 (-147.4 to -133.3)	-125.9 (-133.0 to -118.9)
Week 60	-124.1 (-131.1 to -117.1)	-143.5 (-150.4 to -136.5)
Week 64	-145.4 (-152.4 to -138.4)	-127.8 (-134.7 to -120.9)
Week 68	-137.5 (-144.0 to -130.9)	-142.8 (-149.4 to -136.3)
Week 72	-139.7 (-147.2 to -132.3)	-132.0 (-139.4 to -124.7)
Week 76	-135.3 (-142.2 to -128.3)	-142.8 (-149.8 to -135.9)
Week 80	-146.7 (-154.3 to -139.0)	-132.1 (-139.7 to -124.5)
Week 84	-141.7 (-148.4 to -135.0)	-143.2 (-149.9 to -136.6)
Week 88	-143.9 (-150.7 to -137.2)	-139.3 (-146.0 to -132.6)
Week 92	-144.8 (-151.1 to -138.4)	-148.5 (-154.7 to -142.2)
Week 96	-147.6 (-154.6 to -140.5)	-139.7 (-146.7 to -132.8)
Week 100	-145.7 (-152.7 to -138.7)	-147.1 (-153.9 to -140.2)
Week 104	-147.7 (-154.6 to -140.8)	-143.4 (-150.2 to -136.6)
Week 108	-141.7 (-148.5 to -134.8)	-151.0 (-157.7 to -144.2)
Week 112	-150.1 (-157.1 to -143.1)	-144.3 (-151.3 to -137.4)

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	334 ^[39]	337 ^[40]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 324, 332)	89.2 (86.0 to 92.4)	85.2 (81.6 to 88.8)
Week 8 (n = 321, 325)	87.5 (84.1 to 90.9)	84.3 (80.6 to 88.1)
Week 12 (n = 320, 323)	89.3 (86.1 to 92.5)	85.4 (81.8 to 89.0)
Week 16 (n = 318, 315)	89.2 (86.0 to 92.5)	76.3 (71.8 to 80.8)
Week 20 (n = 307, 306)	82.4 (78.3 to 86.5)	83.4 (79.5 to 87.3)
Week 24 (n = 279, 284)	80.5 (75.9 to 85.0)	77.7 (73.0 to 82.4)
Week 28 (n = 285, 276)	76.9 (72.3 to 81.4)	85.3 (81.3 to 89.2)
Week 32 (n = 291, 285)	86.8 (83.1 to 90.6)	79.1 (74.6 to 83.7)
Week 36 (n = 284, 295)	79.9 (75.5 to 84.3)	83.5 (79.4 to 87.6)
Week 40 (n = 276, 285)	82.1 (77.7 to 86.5)	77.2 (72.5 to 81.9)
Week 44 (n = 273, 264)	75.5 (70.6 to 80.3)	84.9 (80.7 to 89.1)
Week 48 (n = 263, 267)	82.1 (77.7 to 86.5)	74.4 (69.4 to 79.5)
Week 52 (n = 273, 277)	83.1 (78.8 to 87.4)	85.0 (80.9 to 89.1)
Week 56 (n = 271, 276)	84.9 (80.8 to 89.1)	80.3 (75.8 to 84.9)
Week 60 (n = 265, 264)	72.9 (67.9 to 77.9)	82.3 (77.9 to 86.7)
Week 104 (n = 249, 263)	80.0 (75.2 to 84.8)	80.7 (76.1 to 85.4)
Week 108 (n = 243, 253)	77.8 (72.9 to 82.7)	84.7 (80.5 to 88.9)
Week 112 (n = 245, 256)	82.3 (77.7 to 86.9)	76.2 (71.0 to 81.3)

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	334 ^[41]	337 ^[42]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 324, 332)	67.8 (62.9 to 72.7)	58.8 (53.7 to 64.0)
Week 8 (n = 321, 324)	84.5 (80.6 to 88.4)	76.4 (71.9 to 81.0)
Week 12 (n = 321, 324)	87.2 (83.6 to 90.8)	78.5 (74.1 to 82.9)
Week 16 (n = 318, 316)	89.6 (86.3 to 92.9)	59.9 (54.6 to 65.2)
Week 20 (n = 307, 307)	75.1 (70.3 to 79.9)	76.3 (71.6 to 81.0)
Week 24 (n = 279, 284)	70.8 (65.6 to 75.9)	63.9 (58.4 to 69.4)
Week 28 (n = 285, 276)	71.1 (65.9 to 76.2)	78.8 (74.0 to 83.5)
Week 32 (n = 292, 285)	82.2 (77.9 to 86.5)	65.1 (59.6 to 70.6)
Week 36 (n = 285, 295)	74.1 (69.2 to 79.1)	79.9 (75.4 to 84.4)
Week 40 (n = 284, 288)	78.5 (73.9 to 83.1)	67.3 (61.9 to 72.7)
Week 44 (n = 277, 274)	69.6 (64.3 to 74.9)	78.0 (73.1 to 82.8)
Week 48 (n = 268, 279)	75.7 (70.7 to 80.8)	65.8 (60.4 to 71.1)
Week 52 (n = 273, 278)	80.6 (76.0 to 85.2)	79.9 (75.3 to 84.5)
Week 56 (n = 271, 276)	79.0 (74.3 to 83.7)	70.1 (64.7 to 75.4)
Week 60 (n = 267, 274)	67.7 (62.2 to 73.2)	77.5 (72.6 to 82.3)
Week 104 (n = 249, 261)	79.3 (74.5 to 84.2)	74.9 (69.7 to 80.1)
Week 108 (n = 245, 253)	79.6 (74.6 to 84.6)	77.4 (72.4 to 82.5)
Week 112 (n = 245, 256)	80.9 (76.1 to 85.7)	73.1 (67.7 to 78.4)

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 millimetre [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	334 ^[43]	337 ^[44]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 323, 332)	60.8 (55.7 to 66.0)	49.0 (43.8 to 54.2)
Week 8 (n = 321, 324)	74.5 (69.9 to 79.2)	63.1 (58.0 to 68.2)
Week 12 (n = 319, 323)	77.4 (72.9 to 81.9)	66.3 (61.4 to 71.3)
Week 16 (n = 318, 315)	78.8 (74.4 to 83.2)	44.0 (38.6 to 49.4)
Week 20 (n = 307, 306)	64.7 (59.4 to 70.0)	62.2 (56.9 to 67.4)
Week 24 (n = 279, 284)	57.2 (51.6 to 62.9)	48.9 (43.2 to 54.6)
Week 28 (n = 285, 276)	54.8 (49.2 to 60.5)	66.9 (61.5 to 72.3)
Week 32 (n = 292, 285)	71.9 (66.8 to 77.0)	51.2 (45.5 to 56.9)
Week 36 (n = 285, 295)	59.4 (53.7 to 65.1)	66.6 (61.3 to 71.9)
Week 40 (n = 278, 286)	64.8 (59.3 to 70.3)	52.1 (46.3 to 57.9)
Week 44 (n = 275, 266)	51.4 (45.6 to 57.2)	65.5 (59.8 to 71.1)
Week 48 (n = 264, 268)	63.3 (57.6 to 68.9)	47.1 (41.3 to 52.9)
Week 52 (n = 273, 277)	68.4 (63.0 to 73.8)	68.4 (63.1 to 73.8)
Week 56 (n = 271, 276)	67.8 (62.3 to 73.3)	55.3 (49.4 to 61.1)
Week 60 (n = 266, 267)	48.6 (42.7 to 54.4)	62.4 (56.7 to 68.2)
Week 104 (n = 249, 261)	63.0 (57.0 to 68.9)	59.0 (53.1 to 65.0)
Week 108 (n = 243, 253)	60.7 (54.7 to 66.8)	63.6 (57.8 to 69.4)
Week 112 (n = 244, 256)	65.9 (60.0 to 71.8)	54.5 (48.4 to 60.6)

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	334 ^[45]	337 ^[46]
Units: Percentage of participants
number (confidence interval 95%)
Week 4 (n = 325, 332)	5.3 (2.9 to 7.6)	4.9 (2.6 to 7.2)
Week 8 (n = 320, 325)	3.5 (1.5 to 5.5)	4.3 (2.1 to 6.5)
Week 12 (n = 322, 325)	2.9 (1.0 to 4.7)	2.1 (0.6 to 3.7)
Week 16 (n = 318, 316)	1.6 (0.2 to 3.0)	4.4 (2.2 to 6.6)
Week 20 (n = 306, 309)	2.4 (0.7 to 4.1)	3.9 (1.8 to 6.1)
Week 24 (n = 279, 285)	3.3 (1.2 to 5.4)	4.2 (1.9 to 6.6)
Week 28 (n = 285, 276)	2.9 (1.0 to 4.8)	5.8 (3.1 to 8.5)
Week 32 (n = 292, 285)	3.4 (1.4 to 5.5)	3.6 (1.4 to 5.7)
Week 36 (n = 285, 295)	4.3 (1.9 to 6.6)	6.4 (3.7 to 9.2)
Week 40 (n = 284, 291)	7.8 (4.7 to 10.9)	9.9 (6.5 to 13.3)
Week 44 (n = 277, 273)	3.6 (1.5 to 5.8)	8.8 (5.5 to 12.2)
Week 48 (n = 270, 279)	3.4 (1.3 to 5.5)	7.7 (4.6 to 10.7)
Week 52 (n = 273, 278)	2.3 (0.5 to 4.1)	3.5 (1.4 to 5.7)
Week 56 (n = 271, 276)	2.6 (0.7 to 4.5)	5.8 (3.0 to 8.5)
Week 60 (n = 267, 274)	4.2 (1.8 to 6.5)	6.4 (3.6 to 9.2)
Week 104 (n = 249, 263)	3.7 (1.4 to 6.0)	4.9 (2.3 to 7.6)
Week 108 (n = 243, 252)	3.1 (0.9 to 5.4)	7.5 (4.2 to 10.7)
Week 112 (n = 246, 256)	4.0 (1.6 to 6.4)	8.0 (4.7 to 11.2)

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	237	248
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	0.0 ± 4.5	0.4 ± 4.8

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	243	246
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	-3.8 ± 6.9	-3.0 ± 6.9

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	225	236
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	1.2 ± 4.6	1.6 ± 5.0

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	222	233
Units: millimetres squared (mm^2)
arithmetic mean (standard deviation)	-5.4 ± 5.7	-5.0 ± 6.4

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	333	336
Units: Percentage of participants
number (not applicable)
Adverse Event (AE)	88.3	89.3
Serious AE (SAE)	24.0	27.7
AE Leading to Withdrawal from Study Treatment	3.6	2.7
AE of Special Interest (AESI)	4.8	6.8

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	333	336
Units: Percentage of participants
number (not applicable)
Study Eye: Adverse Event (AE)	55.0	56.5
Study Eye: Serious AE (SAE)	4.2	3.9
Study Eye: AE Leading to Withdrawal from Treatment	1.8	0.6
Study Eye: Treatment-related AE	4.2	2.7
Study Eye: Treatment-related SAE	1.2	0.0
Study Eye: AE of Special Interest (AESI)	3.6	3.9
Study Eye: AESI, Drop in VA Score ≥30 Letters	2.7	3.0
Study Eye: AESI, Associated with Severe IOI	0.3	0.3
StudyEye:AESI,Interv Req to Avoid Perm Vision Loss	0.6	0.6
Fellow Eye: AE	39.3	44.3
Fellow Eye: SAE	1.2	3.3
Fellow Eye: AESI	1.2	3.0
Fellow Eye: AESI, Drop in VA Score ≥30 Letters	0.9	2.1
FellowEye:AESI,Inter Req to Avoid Perm Vision Loss	0.3	0.9

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	333	336
Units: Percentage of participants
number (not applicable)
Adverse Event (AE)	75.7	72.9
Serious AE (SAE)	19.8	22.6
AE Leading to Withdrawal from Study Treatment	1.8	2.1
AE of Special Interest (AESI)	0.0	0.3

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	333
Units: micrograms per millilitre (μg/mL)
arithmetic mean (standard deviation)
Baseline (n = 323)	0.0000 ± 0.0005
Week 4 (n = 321)	0.0288 ± 0.0194
Week 16 (n = 304)	0.0337 ± 0.0266
Week 20 (n = 296)	0.0044 ± 0.0062
Week 48 (n = 279)	0.0139 ± 0.0175
Week 76 (n = 258)	0.0057 ± 0.0109
Week 112 (n = 248)	0.0099 ± 0.0140

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	11.5
Treatment-Induced ADA-Positive	11.2
Treatment-Boosted ADA-Positive	0.3

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 A: Faricimab

Reporting group description

Reporting group title

Arm B: Aflibercept

Reporting group description

Serious adverse events	Arm A: Faricimab	Arm B: Aflibercept
Total subjects affected by serious adverse events
subjects affected / exposed	80 / 333 (24.02%)	93 / 336 (27.68%)
number of deaths (all causes)	13	7
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hair follicle tumour benign
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma metastatic
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastric cancer recurrent
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic cancer
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal adenocarcinoma
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tracheal cancer
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Colon neoplasm
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 333 (0.30%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Internal haemorrhage
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Multiple organ dysfunction syndrome
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gait disturbance
subjects affected / exposed	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hernia
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal cyst
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Major depression
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcus test positive
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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
Anaemia postoperative
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal abrasion
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropod bite
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 333 (0.30%)	3 / 336 (0.89%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hip fracture
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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 left ventricular failure
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (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 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	5 / 333 (1.50%)	4 / 336 (1.19%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	3 / 333 (0.90%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Mitral valve prolapse
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis constrictive
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Arrhythmia
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 333 (0.00%)	3 / 336 (0.89%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	2 / 333 (0.60%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 3	1 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Somnolence
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 333 (0.30%)	3 / 336 (0.89%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intensive care unit acquired weakness
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Guillain-Barre syndrome
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Age-related macular degeneration
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neovascular age-related macular degeneration
subjects affected / exposed	1 / 333 (0.30%)	9 / 336 (2.68%)
occurrences causally related to treatment / all	0 / 1	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Cataract
subjects affected / exposed	2 / 333 (0.60%)	5 / 336 (1.49%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal pigment epithelial tear
subjects affected / exposed	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rhegmatogenous retinal detachment
subjects affected / exposed	1 / 333 (0.30%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Subretinal fibrosis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uveitis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal depigmentation
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal tear
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tractional retinal detachment
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal degeneration
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dry age-related macular degeneration
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lens dislocation
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 333 (0.00%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth cyst
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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
Chronic kidney disease
subjects affected / exposed	2 / 333 (0.60%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	2 / 333 (0.60%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Haematuria
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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
Osteoarthritis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scoliosis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis of jaw
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	5 / 333 (1.50%)	4 / 336 (1.19%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	6 / 333 (1.80%)	5 / 336 (1.49%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
Pneumonia bacterial
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sepsis
subjects affected / exposed	1 / 333 (0.30%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Septic shock
subjects affected / exposed	2 / 333 (0.60%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic bacterial infection
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Viral uveitis
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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	2 / 333 (0.60%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 333 (0.30%)	1 / 336 (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 / 333 (0.90%)	0 / 336 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (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	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19 pneumonia
subjects affected / exposed	2 / 333 (0.60%)	2 / 336 (0.60%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Skin infection
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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
Dehydration
subjects affected / exposed	0 / 333 (0.00%)	3 / 336 (0.89%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 333 (0.00%)	1 / 336 (0.30%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Magnesium deficiency
subjects affected / exposed	1 / 333 (0.30%)	0 / 336 (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 A: Faricimab	Arm B: Aflibercept
Total subjects affected by non serious adverse events
subjects affected / exposed	211 / 333 (63.36%)	200 / 336 (59.52%)
Investigations
Intraocular pressure increased
subjects affected / exposed	17 / 333 (5.11%)	14 / 336 (4.17%)
occurrences all number	23	22
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	20 / 333 (6.01%)	20 / 336 (5.95%)
occurrences all number	29	24
Vascular disorders
Hypertension
subjects affected / exposed	24 / 333 (7.21%)	13 / 336 (3.87%)
occurrences all number	25	13
Eye disorders
Conjunctival haemorrhage
subjects affected / exposed	36 / 333 (10.81%)	33 / 336 (9.82%)
occurrences all number	44	40
Cataract
subjects affected / exposed	27 / 333 (8.11%)	36 / 336 (10.71%)
occurrences all number	41	47
Neovascular age-related macular degeneration
subjects affected / exposed	65 / 333 (19.52%)	63 / 336 (18.75%)
occurrences all number	85	77
Dry eye
subjects affected / exposed	18 / 333 (5.41%)	24 / 336 (7.14%)
occurrences all number	27	42
Eye pain
subjects affected / exposed	14 / 333 (4.20%)	18 / 336 (5.36%)
occurrences all number	17	25
Vitreous detachment
subjects affected / exposed	19 / 333 (5.71%)	21 / 336 (6.25%)
occurrences all number	23	33
Vitreous floaters
subjects affected / exposed	23 / 333 (6.91%)	12 / 336 (3.57%)
occurrences all number	30	17
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	22 / 333 (6.61%)	19 / 336 (5.65%)
occurrences all number	25	20
Infections and infestations
Nasopharyngitis
subjects affected / exposed	23 / 333 (6.91%)	35 / 336 (10.42%)
occurrences all number	27	42
Urinary tract infection
subjects affected / exposed	26 / 333 (7.81%)	23 / 336 (6.85%)
occurrences all number	37	27

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.; -Since patient recruitment was expected to take longer in Japan, a specific Japan enrollment plan was established. After the global enrollment phase of the study had been completed, additional patients could be enrolled in a Japan extension to ensure a total enrollment sufficient to support registration in Japan.; -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 (TENAYA)

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 (TENAYA)