Apellis' Pegcetacoplan Showed Continuous, Meaningful Effects At Month 18 In Geographic Atrophy Studies

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  • Apellis Pharmaceuticals Inc APLS announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan continued to reduce geographic atrophy (GA) lesion growth.
  • These data will be included in the U.S. marketing application that the Company plans to submit in Q2 of 2022.
  • In the OAKS study, pegcetacoplan reduced GA lesion growth with both monthly (22%) and every other month treatment (16%), and in the DERBY study, the percentages stood at 13% and 12%, respectively.
  • Also See: Apellis - Sobi's Pegcetacoplan Wins European Approval For Rare Blood Disorder.
  • Pegcetacoplan demonstrated marked improvements in DERBY during months 6-12 with reductions of 17% with monthly and 16% with every-other-month treatment compared to months 0-6, and the treatment effects were sustained through month 18. 
  • The treatment effects observed in DERBY were comparable with OAKS during months 6-18.
  • Data at 18 months from the combined studies show the potential for improving treatment effects with pegcetacoplan over time. 
  • The rate of infectious endophthalmitis was 0.044% per injection, and the rate of intraocular inflammation was 0.23% per injection. 
  • Price Action: APLS shares are up 15.20% at $46.13 during the market session on the last check Wednesday.
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