Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

The FDA has issued another Complete Response Letter (CRL) to Outlook Therapeutics, declining approval of its biologics license application (BLA) for ONS-5010 (bevacizumab-vikg), intended as the first ophthalmic formulation of Avastin for wet age-related macular degeneration (AMD)1.

The FDA cited lack of substantial evidence of effectiveness, specifically that the key NORSE EIGHT trial did not meet its primary efficacy endpoint, although a prior trial (NORSE TWO) did demonstrate effectiveness1.

No additional deficiencies were identified in the BLA apart from efficacy concerns, and Outlook Therapeutics plans to meet with the FDA to clarify requirements for future approval attempts1.

ONS-5010 (Lytenava) has been approved in the EU (May 2024) and UK (July 2024), and commercially launched in Germany and the UK as the first authorized ophthalmic formulation of bevacizumab for wet AMD15.

Outlook conducted a new clinical trial (NORSE EIGHT), reporting results in January 2025 that indicated non-inferiority to Lucentis in efficacy and safety, prompting a BLA resubmission to the FDA in early 20252.

As of August 2025, ONS-5010 remains investigational in the United States and has not received FDA approval13.

Sources:

1. https://eyewire.news/news/fda-once-again-turns-down-outlook-therapeutics-wet-amd-candidate

2. https://www.pearceip.law/2025/01/16/outlook-therapeutics-plans-bla-resubmission-to-fda-for-ophthalmic-bevacizumab-following-positive-clinical-trial-results/

3. https://outlooktherapeutics.com

5. https://www.pearceip.law/2025/06/02/outlook-therapeutics-launches-ophthalmic-bevacizumab-in-uk-and-germany/