By: David Hutton
Positive data from the GALE long-term extension study showed patients developed fewer new scotomatous points with 36 months of both continuous monthly and every-other-month treatment.
A study has found that pegcetacoplan injection (Syfovre, Apellis Pharmaceuticals Inc.) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
These positive data from the GALE long-term extension study were presented at the Clinical Trials at the Summit (CTS) meeting on June 8 in Park City, Utah.1
“Syfovre is the only approved GA treatment to show a benefit on visual function in a prespecified endpoint,” Dilsher Dhoot, MD, presenting author and a vitreoretinal surgeon at California Retina Consultants, Santa Barbara, California, said in the news release. “The vision loss caused by GA is devastating for patients, taking away their ability to drive and read. These groundbreaking data demonstrate Syfovre’s potential to make a meaningful difference for patients.”
According to Apellis, pegcetacoplan injection is the first-ever approved therapy for GA. By targeting C3, it is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. Pegcetacoplan injection is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
According to the news release, in a prespecified microperimetry endpoint, patients developed fewer new scotomatous points with 36 months of both continuous monthly (p=0.0156) and every-other-month (p = 0.1233) treatment compared to patients from the sham crossover group (all p-values nominal). The news release also noted scotomatous points measure areas of the retina that have lost all light sensitivity and therefore are no longer functioning.
“These results further reinforce the importance of slowing GA lesion growth to preserve visual function, adding to the largest body of evidence for a GA treatment,” Caroline Baumal, MD, chief medical officer at Apellis, said in the news release. “As leaders in GA, we are committed to advancing our understanding of the benefits of Syfovre on this progressive and long-term disease.”
GALE study
The GALE Phase 3, multicenter, open-label, extension study is evaluating the long-term efficacy and safety of pegcetacoplan injection in patients with GA secondary to AMD.
According to the news release, the focus of the study is to evaluate the long-term incidence and severity of ocular and systemic treatment-emergent adverse events as well as change in the total area of GA lesions as measured by fundus autofluorescence. More than 80% of participants who completed the OAKS and DERBY studies entered the GALE study. GALE also includes 10 patients previously enrolled in the Phase 1b study of pegcetacoplan for GA.
Moreover, patients in the sham crossover group completed sham treatment from Months 0-24 in the Phase 3 OAKS study and received pegcetacoplan injection from Months 24 to 36. Microperimetry was a key secondary endpoint measured only in the OAKS study, and therefore, patients who crossed over from the OAKS study were included in this analysis.1
OAKS and DERBY studies
The OAKS (n=637) and DERBY (n=621) studies are Phase 3, multicenter, randomly assigned, double-masked, sham-controlled studies comparing the efficacy and safety of pegcetacoplan injection with sham injections across a broad and heterogenous population of patients with GA secondary to AMD.
The company noted in its news release the studies evaluated the efficacy of monthly and every-other-month pegcetacoplan injection in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence.
In Phase 3 studies at 24 months, both every-other-month and monthly pegcetacoplan injections reduced GA lesion growth with increasing effects over time and showed a well-demonstrated safety profile.1
Reference:
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Inc AP. SYFOVRE (pegcetacoplan injection) Preserved Visual Function at 36 Months in GALE Extension Study in Geographic Atrophy (GA). GlobeNewswire News Room. Published June 10, 2024. Accessed June 11, 2024. https://www.globenewswire.com/news-release/2024/06/10/2895884/0/en/SYFOVRE-pegcetacoplan-injection-Preserved-Visual-Function-at-36-Months-in-GALE-Extension-Study-in-Geographic-Atrophy-GA.html
Source: OPHTHALMOLOGY TIMES