US FDA Rejects Outlook Therapeutics' Eye Drug Approval

The US FDA has declined to approve Outlook Therapeutics' drug for treating an eye condition. The drug, ONS-5010/LYTENAVA (bevacizumab-gamma), is an ophthalmic formulation of bevacizumab for use in retinal indications. The company is focused on developing and commercializing the drug for wet age-related macular degeneration, diabetic macular edema, and branch retinal vein occlusion.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Outlook Therapeutics, Inc. (Nasdaq: OTLK) for its resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-gamma) [1]. The drug, an ophthalmic formulation of bevacizumab, is intended for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.

The FDA's decision stems from a lack of substantial evidence of effectiveness, specifically noting that ONS-5010 did not meet its primary efficacy endpoint in the NORSE EIGHT trial [1]. The agency recommended that confirmatory evidence of efficacy be submitted to support the application. Despite this setback, Outlook Therapeutics plans to meet with the FDA to address the deficiency and explore potential pathways for approval [1].

ONS-5010/LYTENAVA is already approved in Europe and the UK for the treatment of wet AMD, with commercial availability in Germany and the UK since June 2025 [1]. The drug's European success provides a proven regulatory path and first-mover advantage as the only approved ophthalmic bevacizumab. Outlook Therapeutics remains committed to providing a safe and effective alternative to compounded Avastin in the United States [1].

The company's resubmission package addresses prior manufacturing concerns, and the NORSE EIGHT trial offers a supportive clinical and safety dataset [2]. Investors await the FDA's decision, which is expected to significantly impact Outlook Therapeutics' future prospects.

References:
[1] https://www.globenewswire.com/news-release/2025/08/28/3140631/0/en/Outlook-Therapeutics-Provides-Regulatory-Update-on-U-S-Food-and-Drug-Administration-Review-of-ONS-5010-LYTENAVA-bevacizumab-vikg-for-the-Treatment-of-Wet-AMD.html
[2] https://seekingalpha.com/article/4816309-outlook-therapeutics-why-odds-point-to-a-favorable-fda-decision