Despite the mixed phase 3 results, the company says it plans to submit NDA to FDA in 2022
Apellis reported the top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Overall, 1258 adults with GA were included in the studies. In OAKS, pegcetacoplan, significantly reduced GA lesion growth by 22% when taken monthly and by 16% when taken every-other-month compared to pooled sham at 12 months, meeting the primary endpoint.
In DERBY, the primary endpoint was not met. Monthly and every-other-month treatment pegcetacoplan reduced GA lesion growth in 12% and 11%, compared to pooled sham at 12 months.
In a prespecified analysis of the combined studies, monthly treatment with pegcetacoplan reduced GA lesion growth by 17% and every-other-month treatment with pegcetacoplan reduced GA lesion growth by 17% (p<0.0001) compared to pooled sham at 12 months.
The company plans to submit a New Drug Application for pegcetacoplan for GA to the FDA in the first half of 2022.
Read the full press release here.
This content is independent editorial sponsored by Astellas. Astellas had no input in the development of this content.
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