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

Low On Cash, Rush Is On To Clarify Agency’s Concerns

 
• By Mandy Jackson

Outlook Therapeutics received a complete response letter citing manufacturing issues and seeking more data for Lytenava (ONS-5010), its bevacizumab injection for wet age-related macular degeneration.

Close up cropped shot, face of senior woman eye looking straight, into distance.
Outlook will request at Type A meeting with the FDA to discuss the CRL • Source: Shutterstock

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...

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