Outlook Therapeutics Seeks FDA Clarification on Confirmatory Evidence for ONS-5010 Approval

Outlook Therapeutics has requested a Type A meeting with the FDA to discuss the complete response letter regarding the biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab to treat wet AMD. The meeting aims to clarify the FDA's requirements for confirmatory evidence of efficacy. The company remains committed to providing patients with a safe and effective alternative to compounded bevacizumab.

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab in the treatment of retina diseases, has requested a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) regarding its biologics license application (BLA) for ONS-5010. The meeting aims to clarify the FDA's requirements for confirmatory evidence of efficacy for the investigational ophthalmic formulation of bevacizumab, designed to treat wet age-related macular degeneration (wet AMD).

ONS-5010, also known as LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), is an ophthalmic formulation of bevacizumab. The FDA's CRL, issued on August 27, 2025, acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but recommended additional confirmatory evidence for the wet AMD treatment. The Type A meeting seeks to clarify the specific confirmatory evidence required by the FDA for approval.

Bob Jahr, Chief Executive Officer of Outlook Therapeutics, commented, "We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL. The Outlook Therapeutics team remains dedicated to our mission to provide patients in the U.S. with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency, and regulatory oversight associated with the use of compounded products."

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. It has received centralized Marketing Authorization in the EU and the UK. In the United States, ONS-5010/LYTENAVA™ is investigational. If approved, it would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.

The company's plans to meet with the FDA to address the Agency's issues come after the FDA issued a CRL for the resubmitted BLA, indicating that the FDA cannot approve the application in its present form. The CRL identified a single deficiency, a lack of substantial evidence of effectiveness. The FDA advised that confirmatory evidence of efficacy be submitted to support the application for ONS-5010.

Outlook Therapeutics intends to continue its efforts to expand into additional markets in Europe. LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. It became commercially available in Germany and the UK in June 2025.

The company will host a corporate update on August 28, 2025, to discuss the regulatory update on the FDA review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD.

References:
[1] https://www.stocktitan.net/news/OTLK/outlook-therapeutics-requests-type-a-meeting-with-nhmnjnjnrb66.html
[2] https://www.biospace.com/press-releases/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