Apellis completes phase 3 study enrollment of geographic atrophy treatment
Enrollment is complete for two pivotal phase 3 studies of intravitreal pegcetacoplan, a targeted C3 therapy, for the treatment of geographic atrophy secondary to age-related macular degeneration.
The DERBY and OAKS studies will include 1,259 patients. The randomized studies will evaluate the efficacy and safety of intravitreal pegcetacoplan (APL-2) compared with sham treatment, according to a press release from Apellis Pharmaceuticals.
The primary outcome for each study will be the reduction in growth of geographic atrophy lesion size, which will be measured by fundus autofluorescence at month 12 and compared with baseline.
The phase 3 studies were initiated after the completion of the phase 2 FILLY study, which showed monthly pegcetacoplan resulted in a 29% reduction of lesion growth compared with sham injections at 12 months.
The FDA granted pegcetacoplan fast track designation for the treatment of geographic atrophy in July 2018.