February 2018. The Company received clearance from the United States FDA to initiate a Phase 3 trial of RPh201 in patients with established NAION19/02/18
Regenera has received clearance from the United States FDA to initiate a Phase 3 trial of RPh201 in patients with established NAION. This multicenter, double-blind, placebo-controlled study 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 improving by 3 lines or more in visual acuity from baseline to Week 26. The study, expected to initiate enrollment in mid-2018, will be conducted in 10 leading centers across the United States with final readout expected in Q4 2019.