Two-year study outcomes show increasing positive effect of pegcetacoplan in GA
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Key takeaways:
- Outcomes at 24 months confirmed the efficacy of Syfovre in reducing GA lesion growth with administration monthly or every other month.
- The beneficial effects increased over time with continuous treatment.
Two-year results from the phase 3 OAKS and DERBY studies evaluating Syfovre for geographic atrophy showed clinically meaningful reduction of lesion growth with increasing effect over time.
The results, published in The Lancet, confirmed the efficacy of Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals) with both monthly and every other month administration in 809 patients vs. 402 sham controls.
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“The treatment effects increasing over time in combination with the junctional zone microperimetry analyses demonstrating a positive signal of visual preservation were both meaningful to me,” senior study author Charles C. Wykoff, MD, PhD, told Healio. “Before Syfovre, patients had nothing to treat their disease, so these data are tremendously impactful for the retina community as physicians discuss this potential treatment, including risks and benefits, with their patients.”
The previous 12-month analysis had shown significant reduction of geographic atrophy (GA) lesion growth in OAKS by 21% with monthly injections and 16% with every other month administration. In DERBY, the respective 12% and 11% reductions in lesion growth did not achieve statistical significance.
The outcomes at 24 months showed that the beneficial effects of Syfovre increase with continuous treatment. Monthly and every other month injection slowed GA lesion growth by 22% and 18% in OAKS and by 19% and 16% in DERBY, respectively.
In OAKS, serious ocular adverse events were reported in five patients (2%) treated monthly, four patients (2%) treated every other month and one control subject (< 1%). In DERBY, they occurred in four patients (2%) with monthly injection, two patients (1%) with injection every other month and two control subjects (1%).
At 24 months, new-onset neovascular age-related macular degeneration was reported in 24 patients (11%), 16 patients (8%) and four subjects (2%) in OAKS and in 27 patients (13%), 12 patients (6%) and nine subjects (4%) in DERBY who received pegcetacoplan monthly, pegcetacoplan every other month and sham, respectively.
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