Outlook Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding its biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg), a treatment candidate for wet age-related macular degeneration (wet AMD). The agency stated it could not approve the application in its current form.
According to Outlook Therapeutics, the CRL cited a single deficiency: a lack of substantial evidence of effectiveness. The FDA noted that the NORSE EIGHT trial did not meet its primary efficacy endpoint and recommended the submission of confirmatory evidence. However, the agency acknowledged that the prior NORSE TWO trial did meet its primary endpoint.
“While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements,” said Bob Jahr, CEO of Outlook Therapeutics. “It is important to also note that the CRL identified no other outstanding deficiencies in our BLA.”
The company plans to engage with the FDA to explore options for moving forward and reaffirmed its commitment to providing an on-label, ophthalmic-grade alternative to compounded Avastin for U.S. patients.
Despite the regulatory setback in the U.S., Outlook Therapeutics is continuing its international expansion. The European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have approved LYTENAVA (bevacizumab gamma) for the treatment of wet AMD. The product became commercially available in Germany and the UK in June 2025, making it the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and UK.
Outlook Therapeutics said it will provide further updates following discussions with the FDA.