On November 3, 2025, Outlook Therapeutics resubmitted its Biologics License Application for ONS‑5010 to the U.S. Food and Drug Administration after a Type A meeting in September 2025 and a Complete Response Letter issued on August 27, 2025.
The resubmission addresses the FDA’s concerns about chemistry, manufacturing, and controls, and it includes additional data to demonstrate efficacy. In particular, the company provided new results from the NORSE EIGHT trial, showing that ONS‑5010 met the primary non‑inferiority endpoint at week 12, a milestone that was not achieved at week 8 in the original submission.
This is the second resubmission for ONS‑5010. The first Complete Response Letter in August 2023 cited CMC and manufacturing issues, while the second in August 2025 cited a lack of substantial evidence of effectiveness. Outlook has also secured marketing authorization for LYTENAVA in the European Union and the United Kingdom, where the product has been commercially available in Germany and the UK since June 2025 and has generated early sales revenue.
The U.S. market for wet age‑related macular degeneration is the largest ophthalmic market, and a first FDA‑approved ophthalmic formulation of bevacizumab would fill a significant unmet need. Outlook’s financial position remains constrained, with a limited cash runway and a reverse stock split completed in 2023, but European sales provide a revenue base that supports ongoing development and regulatory efforts.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.