Outlook Therapeutics Receives FDA Setback But Expands LYTENAVA™ Launch Across Europe

Outlook Therapeutics, Inc. announced that the U.S. FDA has issued a complete response letter (CRL) to its resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab) in the treatment of wet age-related macular degeneration (wet AMD). The FDA stated that the application cannot be approved in its current form. 

“While we are very disappointed with this outcome, we intend 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. We remain committed to providing patients with a safe and effective alternative to compounded Avastin manufactured in the United States. It is also important to note that the CRL identified no other outstanding deficiencies in our BLA,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. 

The CRL cited one deficiency—a lack of substantial evidence of effectiveness—highlighting that ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT trial. While the FDA acknowledged that the NORSE TWO trial did meet its primary endpoint, it recommended that additional confirmatory evidence be provided to support approval.

Outlook plans to request a meeting with the FDA to discuss potential pathways to U.S. approval. Meanwhile, the company will continue expanding in Europe, where its product LYTENAVA™ (bevacizumab gamma) has already received marketing authorization from the European Commission and the UK’s MHRA. Commercial launches have begun in Germany and the UK, making it the first and only approved ophthalmic bevacizumab formulation for wet AMD in Europe.