An exclusion criterion was added to harmonize the protocol with existing recommendation in the IB (pSivida 2017). An exclusion criterion was clarified to harmonize the protocol with existing tests conducted during eligibility screening. The original text for FAI insert delivery was updated. The PK data for FA release from Iluvien in human subjects were updated based on the publicly available 36-month data reported in Campochiaro et al 2013. The screening section was revised to clarify that the physical examination conducted by the investigative site should be consistent with the physical examination typically administered by the investigator in the investigator’s ophthalmology practice. Laboratory testing of electrolytes was revised to allow investigators to use local standard test for bicarbonate. Text was updated throughout to state that investigative sites were allowed to use local standard TB testing and not necessarily require all sites to use a serology TB testing. The text was updated throughout to clarify that the protocol required dilated indirect ophthalmoscopy only, as some investigators had interpreted the protocol to suggest that direct ophthalmoscopy was also required. The ICF sections were revised to accommodate different national requirements regarding the number of signed original ICF forms. The unmasking section was revised to clarify the authority of the investigator and to avoid any suggestion that the investigator must contact PPD/ EyePoint before breaking the mask for a subject. The OCT section was edited to indicate that sites with alternative OCT instruments were allowed to participate in the study. Anterior chamber cell scoring convention and vitreous haze scoring convention figures were added to clarify the scoring convention that was used in the study for the recurrence of uveitis.

The exclusion criteria were updated to: - Clarify that the exclusion criteria pertain to the study eye. - Clarify that concurrent therapy of the study eye with any IOP-lowering medication is an exclusion criterion. Permit the enrollment of subjects with previous, successful incisional surgery to control IOP (e.g., filtration surgery, shunt, or tube placement) and the following: - Stable IOP in the normal range (10-21 mmHg) - No concurrent therapy with IOP-lowering medication The IOP section was updated to clarify that applanation tonometers with different brand names were acceptable to use in the study.

The concomitant medications/procedures section was revised to clarify the conditions under which topical steroid use was permitted at time of study entry and at time following an ocular surgical procedure. Revision clarified conditions under which topical steroid use should be used to treat recurrences of uveitis. The data imputation section was updated for the conditions under which recurrence of uveitis would be imputed in the efficacy analysis. The measurement of BCVA by EDTRS was updated to clarify that the Tumbling E-ETDRS chart would be used for subjects who were illiterate or not familiar with the standard English alphabet.

Revisions made as part of Amendment 4 for the US and EMEA countries were applied in Amendment 7 for India. Exclusion criterion regarding positive test for HIV, TB, or syphilis was clarified; positive HIV or syphilis test at screening would result in exclusion. An exclusion criterion was added to exclude subjects with infectious mycobacterial uveitis. The FAI insert injection procedure was revised to clarify that administration of a second FAI insert within the study eye was not permitted.

The primary efficacy endpoint analysis was revised from Month 12 to Month 6. Text was revised throughout the protocol for consistency with revised timing of the primary efficacy endpoint analysis. Exploratory analyses text was revised throughout the protocol to be consistent with the revised timing of the primary efficacy endpoint analysis (Month 6). Efficacy and safety data analyses were revised for consistency with revised timing of primary efficacy endpoint analysis (Month 6). Sample size was adjusted for consistency with revised timing of primary efficacy endpoint analysis (Month 6), assuming that 80% of events observed within 12 months were observed within 6 months.

The visit window for the Month 6 and Month 9 study visits was revised to ±28 days.