A post hoc analysis of data from the GALE long-term extension study indicates that 5 years of continuous treatment with injections of pegcetacoplan (Syfovre; Apellis Pharmaceuticals) delayed progression of geographic atrophy (GA) by roughly 1.5 years in patients with nonsubfoveal GA, compared with projected sham.
The GALE study includes nearly 800 patients who had previously completed the phase 3 OAKS and DERBY trials and continued the same dosing regimens, either monthly or every other month. The study relied on a projected sham arm to estimate GA progression from months 24 to 60, based on linear growth observed in the original OAKS and DERBY sham cohorts and validated through fellow-eye analysis. Safety outcomes through 5 years were consistent with previously reported data, with no new ocular or systemic adverse events identified, the company said in a press release.
“These long-term results show that early and continuous treatment with Syfovre can meaningfully delay the natural course of GA,” said study investigator Dilsher S. Dhoot, MD, of California Retina Consultants. Apellis reports it will present detailed data at an upcoming medical meeting. RP







