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Phase 3 OAKS and DERBY studies show clinically meaningful reduction in GA lesion growth

News
Article

These continued studies also demonstrate a well-tolerated safety profile in a broad population of more than 1,200 patients.

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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). (Adobe Stock / Trsakaoe)

Results from the phase 3 OAKS and DERBY studies evaluating pegcetacoplan injection (SYFOVRE) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) were published in The Lancet. The results note that the 24-month results saw clinically meaningful reduction of GA lesion growth with increasing effects over time in both every-other-month and monthly injections. The results also noted a well-demonstrated safety profile in a broad population of more than 1,200 patients.1

Charles Wykoff, MD, PhD, senior author and director of research, Retina Consultants of Texas shared why he sees these results as an important step in treating GA in the press release1, saying, “The increasing treatment effects of SYFOVRE over time with both monthly and every-other-month dosing are exciting to see and meaningful for the field. The vision loss caused by GA takes a tremendous toll on patients and their families, impacting independence and well-being. SYFOVRE is a major advance for patients living with this progressive and relentless disease.”

Caroline Baumal, MD, chief medical officer, Apellis Pharmaceuticals also shared why these phase 3 results are important for bringing this treatments solution to additional countries around the world, saying “These 24-month data demonstrate that SYFOVRE is a clinically meaningful treatment for GA, and we are proud these results were published in 1 of the world's most prestigious peer-reviewed journals. With SYFOVRE’s approval in the United States and 5 additional applications under review globally, we are working urgently to bring this important treatment to patients in need worldwide.”1

Publication co-first authors are Jeffrey Heier, MD, and Eleonora Lad, MD, PhD.

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.1

Reference:
  1. The Lancet Publishes 24-Month Results from Phase 3 Studies of SYFOVRE® (pegcetacoplan injection) for Geographic Atrophy (GA). Apellis Pharmaceuticals, Inc. October 20, 2023. Accessed October 23, 2023. https://www.globenewswire.com/news-release/2023/10/20/2763970/0/en/The-Lancet-Publishes-24-Month-Results-from-Phase-3-Studies-of-SYFOVRE-pegcetacoplan-injection-for-Geographic-Atrophy-GA.html
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