Outlook Aims To Reverse US FDA’s Rejection Of Bevacizumab For AMD

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 in the CRL that it could not approve the BLA in the current review cycle due to a lack of substantial clinical evidence, as well as several chemical manufacturing and control (CMC) issues and open observations from pre-approval manufacturing