FDA Declines Outlook Therapeutics' Wet AMD Drug Application In Present Form; Company Pursues Approval Path, Plans EU Market Growth

Author: Benzinga Newsdesk | August 28, 2025 06:33am
FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLAOutlook Therapeutics plans to work with FDA to address the Agency's issuesCompany to host a conference call and webcast today, August 28th at 8:30 AM

• FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA
• Outlook Therapeutics plans to work with FDA to address the Agency's issues
• Company to host a conference call and webcast today, August 28th at 8:30 AM ET

ISELIN, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).

The CRL included only one deficiency, for a lack of substantial evidence of effectiveness. In the CRL, the FDA advised that, because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness.

In addition to requesting a meeting with the FDA to explore pathways for potential approval in the U.S., Outlook Therapeutics intends to continue its efforts to expand into additional markets in Europe. As previously announced, LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In June 2025, LYTENAVA™ (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK.

Posted In: OTLK