Investigator Says Apellis' Lead Product Shows 'First Direct Evidence Of Slowing Geographic Atrophy Lesion Growth'

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.