Apellis reports mixed results for pegcetacoplan for geographic atrophy
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Apellis Pharmaceuticals reported topline results from two phase 3 studies investigating pegcetacoplan in patients with geographic atrophy secondary to age-related macular degeneration, according to a press release.
DERBY and OAKS are multicenter, randomized, double-masked, sham-controlled studies investigating the efficacy and safety of intravitreal pegcetacoplan.
OAKS met its primary endpoint at 12 months, showing statistical significance in monthly and every other month injections by demonstrating a reduction in GA lesion growth of 22% (P = .0003) and 16% (P = .005), respectively, compared with pooled sham.
DERBY did not meet its primary endpoint at 12 months, showing lesion growth reduction of 12% and 11% with monthly and every other month injections, respectively, compared with pooled sham.
When the studies were combined in a prespecified analysis, lesion growth at 12 months was reduced by 17% (P < .0001) with monthly pegcetacoplan treatment and by 14% (P = .0012) with every other month pegcetacoplan treatment compared with pooled sham.
The therapy was well tolerated in both studies, with a pooled rate of new-onset exudations of 6% in the monthly groups and 4.1% in the every other month groups. There were two confirmed cases of infectious endophthalmitis and one case of suspected infectious endophthalmitis in the injection eye across 6,331 injections. There were 13 intraocular inflammation events and no cases of retinal vasculitis or retinal vein occlusion.
“Across our ophthalmology development program, pegcetacoplan has demonstrated an efficacy and safety profile with both monthly and every other month dosing that we believe supports treatment for GA patients,” Federico Grossi, MD, PhD, chief medical officer at Apellis, said in the release.
Apellis intends to submit a new drug application for pegcetacoplan to treat geographic atrophy to the FDA in the first half of 2022.
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