Outlook Therapeutics: FDA cannot approve current application

Outlook Therapeutics: FDA cannot approve current application

Outlook Therapeutics (NASDAQ: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, has received a significant setback from the U.S. Food and Drug Administration (FDA). The FDA issued a Complete Response Letter (CRL) for ONS-5010/LYTENAVA™ (bevacizumab-vikg), the company's wet AMD treatment candidate, indicating that the application cannot be approved in its current form due to a lack of substantial evidence of effectiveness.

The CRL highlighted that while the NORSE TWO trial met its primary endpoint, the NORSE EIGHT trial did not. This discrepancy led the FDA to recommend additional confirmatory efficacy evidence before considering approval. Despite this setback, LYTENAVA™ has already received Marketing Authorization in the European Union and the United Kingdom, with commercial availability established in Germany and the UK since June 2025 as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment.

The FDA's rejection of Outlook's wet AMD treatment is a substantial challenge that likely requires additional clinical trials, involving significant time (likely 1-2+ years) and capital investment. For a smaller biopharmaceutical company like Outlook, this represents both a financial and strategic hurdle. However, the company has secured a potential revenue stream through its European commercialization efforts.

Outlook Therapeutics plans to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States. The company remains committed to providing patients with a safe and effective alternative to compounded Avastin manufactured in the United States.

The CRL identified no other outstanding deficiencies in the company's biologics license application (BLA), which is a positive development. Outlook Therapeutics will continue its efforts to expand into additional markets in Europe and will host a corporate update conference call and webcast today, August 28, 2025, at 8:30 AM ET.

References:
[1] https://www.stocktitan.net/news/OTLK/outlook-therapeutics-provides-regulatory-update-on-u-s-food-and-drug-nbyjrm2bh7f4.html