SYFOVRE (pegcetacoplan injection) Continued to Demonstrate Increasing Treatment Effects Over 30 Months in Patients with Geographic Atrophy (GA) - Seite 2

Sham-treated patients in the Phase 3 OAKS and DERBY studies were eligible to transition to SYFOVRE treatment in GALE after Month 24, so a projected sham arm was used to estimate the growth of GA lesions without treatment between Months 24 and 30. The projected sham arm was estimated as the average 6-month mean rate of change in the OAKS and DERBY sham arms through Month 24.

The safety profile of SYFOVRE in the GALE study continued to be consistent with previously reported Phase 3 data. The rate of exudative AMD is consistent with Phase 3 studies, with 7.5 and 7.2 events (monthly) and 3.9 and 3.6 events (EOM) per 100 patient years at Months 24 and 30, respectively. Between Months 24 and 30, zero non-serious adverse events of ischemic optic neuropathy (ION) were reported in either treatment group, and one serious adverse event of ION was reported in the monthly group. No cases of endophthalmitis were reported between Months 24 and 30. The rate of intraocular inflammation (IOI) was 0.26% per injection among all SYFOVRE-treated patients in the Phase 3 program. Zero events of retinal vasculitis were observed in the SYFOVRE clinical trial program, following more than 23,000 injections to date.

About the GALE Long-Term Extension Study
GALE (n=792) is a Phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety of SYFOVRE (pegcetacoplan injection) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The objectives of the study are to evaluate the long-term incidence and severity of ocular and systemic treatment emergent adverse events as well as change in the total area of GA lesions as measured by fundus autofluorescence. More than 80-percent of participants who completed the OAKS and DERBY studies entered the GALE study. GALE also includes 10 patients who were previously enrolled in the Phase 1b study of pegcetacoplan for GA.

Patients included in the 30-month GALE lesion growth reduction analyses were in the SYFOVRE treatment arms through Month 24 in the OAKS and DERBY studies and remained on the same regimen in GALE.

About the Phase 3 OAKS and DERBY Studies
OAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of SYFOVRE (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence.