Apellis has announced that seven abstracts will be presented at the American Society of Retina Specialists Annual Scientific Meeting including safety and efficacy data for the company’s pegcetacoplan injection for geographic atrophy (GA).
Apellis Pharmaceuticals, Inc. will feature in seven abstracts to be presented as oral presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting. The meeting will take place July 28 to August 1 in Seattle, Washington. Among the presentations, data will be shared that reinforces the efficacy and safety profile of Apellis’s pegcetacoplan injection (SYFOVRE), the first treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).1
Caroline Baumal, MD, chief medical officer at Apellis gave insight on the forth coming data in the news release saying, “The breadth of SYFOVRE data at ASRS is a testament to the excitement surrounding the first and only FDA approved treatment for GA, which provides flexible dosing and slows GA lesion growth with increasing treatment effects over time. Among our seven oral presentations this year, we are thrilled to present data for the first time from the GALE long-term extension study of SYFOVRE.”1
The presentations featuring Apellis include:
GALE is a Phase 3, multicenter, open label, extension study to evaluate the long-term safety and efficacy of SYFOVRE® (pegcetacoplan injection) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The objectives of the study are 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 percent of participants who completed the OAKS and DERBY studies entered the GALE study.
About the Phase 3 OAKS and DERBY Studies
OAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of SYFOVRE® (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE 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 SYFOVRE reduced GA lesion growth with increasing effects over time and showed a well-demonstrated safety profile.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide. It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.
About SYFOVRE® (pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration.