Posted by Michael Wonder on 24 Jul 2018
Apellis Pharmaceuticals’ APL-2 receives fast track designation from FDA for the treatment of patients with geographic atrophy
24 July 2018 - Apellis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the Company’s APL-2, a novel inhibitor of complement factor C3 as a next generation monotherapy, for the treatment of patients with geographic atrophy, an advanced form of age-related macular degeneration.
Apellis plans to initiate a Phase 3 trial for patients with GA later this year which will consist of two identical, prospective, multicenter, randomised, double-masked, sham-injection controlled studies to assess the efficacy and safety of multiple intra-vitreal injections of APL-2 in patients with geographic atrophy.
