Apellis Reports Five-Year GALE Data: SYFOVRE Slows Geographic Atrophy Progression By 1.5 Years

Apellis Pharmaceuticals, Inc., announced new findings from a post hoc analysis of the GALE extension study, revealing that continuous treatment with SYFOVRE® (pegcetacoplan injection) for five years significantly delayed the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Results showed that both monthly and every-other-month dosing of SYFOVRE slowed GA lesion growth by approximately 1.5 years compared to sham or projected sham treatments in patients with nonsubfoveal GA.

“I’m very encouraged by these long-term results, which show that early and continuous treatment with SYFOVRE can meaningfully delay the progression of GA,” said Dilsher Dhoot, M.D., California Retina Consultants. “Importantly, these data indicate that SYFOVRE alters the natural course of this disease, which causes irreversible vision loss and profoundly impacts patients’ daily lives.”

The GALE study (n=792) is a Phase 3, multicenter, open-label, long-term extension trial assessing the efficacy and safety of SYFOVRE in patients who previously participated in the pivotal OAKS and DERBY trials. More than 80% of participants from those trials enrolled in GALE to continue treatment. The study evaluates long-term outcomes, including ocular and systemic adverse events and changes in GA lesion area measured through fundus autofluorescence imaging.

“These five-year results underscore the transformative and durable impact of targeting C3 with SYFOVRE to delay the progression of GA,” said Caroline Baumal, M.D., chief medical officer, Apellis. “With the most extensive data set in GA, our broad clinical and real-world experience has greatly advanced the retina community’s understanding of this devastating disease and reinforced Apellis’ leadership.”

To measure long-term impact, patients treated with SYFOVRE through Month 24 in OAKS and DERBY continued their respective regimens in GALE. As sham-treated patients transitioned to active therapy after Month 24, researchers used a projected sham arm, based on validated lesion growth data from earlier phases, to estimate untreated progression. The five-year analysis reinforces SYFOVRE’s role as the first and only approved treatment to slow GA progression, marking a milestone in long-term management of advanced AMD.