Apellis Pharmaceuticals today announced data from the GALE extension study following 30 months of continuous treatment with SYFOVRE (pegcetacoplan injection), the first and only FDA-approved treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 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 (ASRS) Annual Scientific Meeting.
“The GALE results show that SYFOVRE continues to demonstrate robust and increasing effects through 30 months with both monthly and every-other-month treatment,” said Caroline Baumal, M.D., chief medical officer, Apellis. “We are especially excited by the data showing that SYFOVRE reduced GA lesion growth by up to 45% in patients with nonsubfoveal lesions.”
In GALE, SYFOVRE reduced GA lesion growth with both monthly (39%; p<0.0001) and every-other-month (EOM) (32%; p<0.0001) treatment between Months 24 and 30 compared to the projected sham arm (all p-values nominal).
Additionally, SYFOVRE reduced nonsubfoveal GA lesion growth with monthly (45%; p<0.0001) and EOM (33%; p=0.0023) treatment between Months 24 and 30 compared to the projected sham arm.
“These positive long-term results deepen our understanding of SYFOVRE as a meaningful therapy for this progressive and irreversible disease, adding to the most robust dataset ever collected in GA,” said Nathan Steinle, M.D., presenting author, California Retina Consultants. “It is very encouraging to see that SYFOVRE continues to work better and better the longer a patient is on treatment.”
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.
