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  • Apellis Pharmaceuticals Inc APLS announced new data from the 24-month Phase 3 OAKS study of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration.
  • Investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment. 
  • Apellis’ drug pegcetacoplan led to less retinal sensitivity loss versus sham within 250 microns on either side of the GA lesion over 24 months.
  • Related: Apellis’s Pegcetacoplan Shows Increased Effects In Geographic Atrophy At Two Years.
  • Microperimetry was a key secondary endpoint measured only in the OAKS study. Statistically significant differences were not observed between pegcetacoplan and sham, given the large area of the retina assessed.
  • Two post hoc analyses of microperimetry data showed positive trends with increasing effects over time, demonstrating that both monthly and every-other-month pegcetacoplan treatment preserved visual function of retinal cells near the GA lesion border compared to sham. 
  • The results will be included in the European marketing application that the company plans to submit by the end of this year. 
  • The U.S. marketing application is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26.
  • Price Action: APLS shares are down 12.7% at $59.62 during the premarket session on the last check Monday.

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