Apellis Pharmaceuticals APLS revealed top-line data readout at 24 months showing increased effects over time with intravitreal pegcetacoplan in the Phase 3 DERBY and OAKS studies in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The DERBY study, that enrolled 621 patients and the OAKS study, which enrolled 637 patients are Phase 3 multicenter sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Pegcetacoplan continued to demonstrate a favorable safety profile, consistent with safety data to date and longer-term exposure to intravitreal injections.
Between months 18-24, the pegcetacoplan treatment effect accelerated compared to previous six-month periods, with robust reductions of GA lesion growth versus sham. No cases of endophthalmitis were reported in the final six months.
Jeffrey Eisele, Chief development officer, commented: ”These data further reinforce the breakthrough potential of pegcetacoplan, with both monthly and every-other-month treatment demonstrating increased effects across a broad patient population over 24 months. With a U.S. PDUFA date in November and an EU submission planned later this year, we are committed to bringing pegcetacoplan to patients as quickly as possible.”
The company is planning to include these two years study results in the marketing authorization application to be submitted to European Medicines Agency by the end of this year.
The company believes that pegcetacoplan is potential to become the first-ever treatment for GA with a FDA target action date of Nov. 26, 2022.
Price Action: Apellis shares traded higher in the pre-market, but currently trading around 7 percent down at $61.87 on Wednesday at the time of publication.
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