This multicenter, double-blind, placebo-controlled Phase 3 trial of RPh201 will enroll 234 patients diagnosed with NAION at least one year prior to enrollment into the study. Patients will be randomized and receive twice-weekly injections of RPh201 or placebo over a six month period. The primary endpoint of the study is the proportion of patients with visual acuity improving by 3 lines or more from baseline to Week 26. The study will be conducted in 12 leading centers across the United States.
Recently, FDA has granted Fast Track designation to Regenera’s leading drug candidate, RPh201, for this indication.