Five-year GALE study data announced

Apellis Pharmaceuticals recently announced post hoc analysis data of the GALE extension study. This new data is the result of five years of patients continuously treated with SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).¹

The company reported that pegcetacoplan injection—both monthly and every other month—delayed GA lesion growth by around 1.5 years when compared to sham.¹

The phase 3 GALE study is a multicenter, open-label extension study of the OAKS and DERBY studies evaluating the long-term efficacy and safety of pegcetacoplan injection (SYFOVRE), the first-ever approved treatment for GA.¹

Patients from the OAKS and DERBY studies as part of the treatment arms through month 24 remained on the same regimen and were included in the GALE study.¹

“These five-year results underscore the transformative and durable impact of targeting C3 with SYFOVRE to delay the progression of GA,” Caroline Baumal, MD, chief medical officer of Apellis, said in a press release.¹

“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.”

During the American Academy of Ophthalmology 2025, the Eye Care Network caught up with Esther Lee Kim, MD, who walked us through key points of the GALE study.

“What’s great about the pegcetacoplan studies is we’re going to have five years’ worth of data, which is the largest database of GA trials,” Kim said.²

“This really has allowed us to learn more about GA as a disease entity, in terms of even understanding natural progression… I think it just provides us with a holistic view. I think what’s good to keep in mind moving forward is, in a nutshell, we haven’t seen any new safety signals, be it in clinical trials or even in the real world, but we do see this increasing, continuous efficacy over time, with those being treated earlier seeing the greatest benefit.”

Apellis said that, although detailed results will be presented at a future medical meeting, the safety profile of pegcetacoplan injection through the five-year extension study remained consistent with previously reported data.¹

“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,” Dilsher Dhoot, MD, California Retina Consultants, said in a press release.¹

“Importantly, these data indicate that SYFOVRE alters the natural course of this disease, which causes irreversible vision loss and profoundly impacts patients’ daily lives.”

Reference:

1. Apellis Announces 5-Year GALE Data Showing SYFOVRE® (pegcetacoplan injection) Delayed Progression of Geographic Atrophy by ~1.5 Years | Apellis Pharmaceuticals, Inc. Apellis Pharmaceuticals, Inc. Published 2025. Accessed November 12, 2025. https://investors.apellis.com/news-releases/news-release-details/apellis-announces-5-year-gale-data-showing-syfovrer

2. Lee E, Crago SM, Stevenson S. AAO 2025: Clinical outcomes of early vs delayed pegcetacoplan treatment in GA. Ophthalmologytimes.com. Published October 19, 2025. Accessed November 13, 2025. https://www.ophthalmologytimes.com/view/aao-2025-clinical-outcomes-of-early-vs-delayed-pegcetacoplan-treatment-in-ga