Outlook Therapeutics Requests Type A Meeting with FDA
1. OTLK requested FDA Type A Meeting regarding ONS-5010's CRL. 2. FDA acknowledged safety but requires confirmatory evidence for efficacy. 3. OTLK's goal is to provide a safe alternative to off-label bevacizumab. 4. ONS-5010 could be the first approved ophthalmic bevacizumab in the U.S. 5. LYTENAVA™ has received European approvals but awaits U.S. approval.