FDA accepts resubmitted ONS-5010 BLA from Outlook Therapeutics

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) from Outlook Therapeutics for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

ONS-5010 is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human VEGF and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.¹

Earlier this year, the FDA issued a complete response letter (CRL) to Outlook for its BLA for ONS-5010.² The CRL included only 1 deficiency, which was due to a lack of substantial evidence of effectiveness. At the time, the FDA advised in the CRL that because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, confirmatory evidence of efficacy should be submitted to support the application for ONS-5010.

Following the CRL, Outlook requested a Type A meeting with the FDA, seeking to clarify details of the confirmatory evidence required by the FDA in the CRL.³

This was the second Type A meeting requested by Outlook regarding ONS-5010 and the second CRL issued by the FDA for ONS-5010. The first Type A meeting request in September 2023 followed the first CRL issued on August 29, 2023.⁴ For the 2023 submission, it was noted that the FDA “could not approve the BLA during the review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”

After the CRL in 2023, Outlook Therapeutics stock underwent a 1-for-20 reverse stock split as “part of the Company’s plan to regain compliance with the minimum bid price ($4 per share) requirement for continued listing on the Nasdaq Capital Market.”⁵

According to the company, the most recent BLA resubmission is considered a complete, Class 1 response to the CRL received in August, which results in a 60-day review period from the date of resubmission. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025.¹

Bob Jahr, CEO of Outlook Therapeutics, commented on the acceptance, saying, “Our team has worked diligently to address the feedback from the agency, strengthen the resubmitted BLA, and resolve the outstanding issue highlighted in the Complete Response Letter (CRL) from August 2025.”

If approved, ONS-5010 will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD.

In March 2024, the European Medicines Agency (EMA) issued a positive Committee for Medicinal Products for Human Use (CHMP) opinion on ONS-5010. In June 2025, LYTENAVA (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD.

References:

1. Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD. Published November 13, 2025. Accessed November 13, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-acceptance-biologics-license

2. Harp MD. FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010. Published August 28, 2025. Accessed November 13, 2025. https://www.ophthalmologytimes.com/view/fda-issues-complete-response-letter-to-outlook-therapeutics-for-resubmitted-bla-for-ons-5010

3. Outlook Therapeutics requests Type A meeting with FDA following second CRL for ONS-5010. Published September 3, 2025. Accessed November 13, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-requests-type-a-meeting-with-fda-following-second-crl-for-ons-5010

4. Hutton D. FDA issues CRL for Outlook Therapeutics’ ONS-5010. Published August 30, 2025. Accessed November 13, 2025. https://www.ophthalmologytimes.com/view/fda-issues-crl-for-outlook-therapeutics-ons-5010

5. Harp MD. Outlook Therapeutics stock undergoes 1-for-20 reverse stock split. Published March 14, 2024. Accessed November 13, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-stock-undergoes-1-for-20-reverse-stock-split