Outlook Therapeutics Resubmits Biologics License Application for ONS-5010 for Wet AMD

Outlook Therapeutics has resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010, an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (AMD).1

Announced on November 3, 2025, this resubmission follows the receipt of official minutes from an FDA Type A meeting, which was completed on September 29, 2025. If approved, ONS-5010 will be branded as LYTENAVA (bevacizumab-vikg) and will become the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD.1

“The resubmission of our BLA for ONS-5010 marks an important step forward in our mission to deliver a safe and effective ophthalmic bevacizumab for the treatment of wet AMD in the United States,” Bob Jahr, chief executive officer of Outlook Therapeutics, said in a statement. “Based on our productive meeting with the FDA in September, we believe this resubmission will resolve the outstanding issue highlighted in the Complete Response Letter (CRL) we received in August 2025.”1

ONS-5010 is a recombinant humanized monoclonal antibody which selectively binds to all isoforms of VEGF and neutralizes its biologic activity through a steric blocking of VEGF’s binding to its Fit-1 and KDR receptors. After intravitreal injection, this binding to VEGF prevents its interaction with its receptors on the surface of endothelial cells, which reduces proliferation, vascular leakage, and new blood vessel formation in the retina.1

Outlook Therapeutics’ last submission of ONS-5010 for regulatory approval was on February 28, 2025, following results from the NORSE EIGHT trial and additional chemistry, manufacturing, and controls (CMC) data requested by the FDA. This was a randomized, controlled, parallel-group, masked, non-inferiority study which enrolled 400 newly diagnosed patients with wet AMD. Investigators randomly assigned these participants in a 1:1 ratio to either 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections, which were received at day 0, week 4, and week 8 visits.2

Ultimately, ONS-5010 showed clinically meaningful anatomic and functional improvements across all timepoints. Best-corrected visual acuity (BCVA) data also demonstrated an improvement in vision which increased over time. The data set also highlighted a similar anatomical response between treatments, with a reduction in central retinal thickness -123.9 microns for the ONS-5010 arm and -127.3 microns for the ranibizumab group.2

However, investigators reported a mean 4.2 letter improvement in BCVA among patients treated with ONS-5010, which did not meet the prespecified non-inferiority endpoint at week 8. Given the endpoint was set forth by agreement with the FDA, Outlook Therapeutics received a CRL noting a lack of substantial evidence of effectiveness. After this decision, Outlook Therapeutics requested the Type A meeting which led to this current resubmission.3

ONS-5010 has already been approved by the European Commission and has received MHRA Marketing Authorization for wet AMD treatment and has launched commercially in both Germany and the UK.1

References

1. Outlook Therapeutics. Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010. November 3, 2025. Accessed November 3, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-re-submits-biologics-license-application

2. Outlook Therapeutics. Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the US Food and Drug Administration. February 28, 2025. Accessed November 3, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application-0

3. Outlook Therapeutics. Outlook Therapeutics Provides Regulatory Updates on US Food and Drug Administration Review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD. August 28, 2025. Accessed November 3, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug