Apellis announces data from GALE extension study of SYFOVRE

Apellis Pharmaceuticals announced data from the GALE extension study following 30 months of continuous treatment with SYFOVRE, the first and only FDA approved treatment for geographic atrophy secondary to age-related macular degeneration. The data, which reinforce the long-term efficacy and safety of SYFOVRE, were reported during an oral presentation at the American Society of Retina Specialists Annual Scientific Meeting. In GALE, SYFOVRE reduced GA lesion growth with both monthly and every-other-month treatment between Months 24 and 30 compared to the projected sham arm. Additionally, SYFOVRE reduced nonsubfoveal GA lesion growth with monthly and EOM treatment between Months 24 and 30 compared to the projected sham arm. 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 and 3.9 and 3.6 events per 100 patient years at Months 24 and 30, respectively. Between Months 24 and 30, zero non-serious adverse events of ischemic optic neuropathy 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 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.