Apellis Presents 18-Month Results of Pegcetacoplan in P-III (DERBY) and (OAKS) Studies for the Treatment of Geographic Atrophy at ARVO 2022
Shots:
- The P-III (DERBY) & (OAKS) studies evaluate pegcetacoplan (IVI) in 621 & 637 patients with GA related to AMD. The company plans to submit an NDA to the US FDA in Q2’22
- The results showed a reduction in extrafoveal & foveal GA lesion growth in (OAKS) study by 33% & 18% in qm; 17% & 19% in every-other-mos. In (DERBY) study, 17% & 9% in qm; 23% & 4% in every-other-mos. along with favorable safety profile which was consistent with safety rates @12mos. & longer-term exposure
- The combined rate of new-onset exudations in qm, every other mos., & sham (9.5%, 6.2%, & 2.9%). The therapy showed a robust effect in patients with extrafoveal lesions & improved effect with foveal lesions
Ref: Globenewswire | Image: Apellis
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