Outlook Therapeutics, Inc. planned to have its first drug approved before the end of 2023, which would have given the company a reason to raise fresh capital. Instead, Outlook revealed on 30 August that the US Food and Drug Administration issued a complete response letter (CRL) rejecting Lytenava (ONS-5010), a proprietary formulation of bevacizumab, for the treatment of wet age-related macular degeneration (AMD).
Iselin, NJ-based Outlook said the FDA acknowledged ONS-5010’s efficacy in the pivotal Phase III NORSE TWO clinical trial, but indicated...
