Outlook Therapeutics Submits Type A Meeting Request to FDA.

Outlook Therapeutics has submitted a Type A meeting request to the FDA to discuss a complete response letter regarding the biologics license application for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet AMD treatment. The FDA acknowledged the NORSE TWO pivotal trial met safety and efficacy endpoints but recommended confirmatory evidence to support the application. The meeting seeks to clarify the details of the required confirmatory evidence.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) has requested a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss a complete response letter (CRL) regarding their biologics license application (BLA) for ONS-5010. The 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 age-related macular degeneration (AMD) treatment.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab designed to provide a regulated alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD. The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA for approval.

The company previously submitted the BLA in February 2025, and the FDA accepted the resubmission in April 2025. The BLA resubmission was based on the efficacy and safety demonstrated in the NORSE EIGHT clinical trial, as well as additional CMC information requested by the FDA. However, the NORSE EIGHT trial did not meet its primary efficacy endpoint, prompting the FDA to recommend additional evidence for ONS-5010.

Outlook Therapeutics plans to meet with the FDA to explore approval pathways and expand into European markets. 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.

The NORSE trials demonstrated a strong benefit-to-risk safety profile, with only one ocular inflammation adverse event across all three registration trials. The most common adverse reaction reported in patients receiving bevacizumab-vikg was conjunctival hemorrhage associated with the needle injection procedure (5%).

The company plans to request a meeting with the FDA to explore pathways for potential approval in the US. Additionally, the company stated its intention to continue its efforts to expand into additional markets in Europe.

References:
[1] 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. Published August 28, 2025. Accessed August 28, 2025. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug
[2] Harp MD. FDA accepts biologics license application from Outlook Therapeutics for ONS-5010 for the treatment of wet AMD. Published April 9, 2025. Accessed August 28, 2025. https://www.ophthalmologytimes.com/view/fda-accepts-biologics-license-application-from-outlook-therapeutics-for-ons-5010-for-the-treatment-of-wet-amd
[3] Hutton D. FDA issues CRL for Outlook Therapeutics’ ONS-5010. Published August 30, 2025. Accessed August 28, 2025. https://www.ophthalmologytimes.com/view/fda-issues-crl-for-outlook-therapeutics-ons-5010
[4] Harp MD. Outlook Therapeutics stock undergoes 1-for-20 reverse stock split. Published March 14, 2024. Accessed August 28, 2025. https://www.ophthalmologytimes.com/view/outlook-therapeutics-stock-undergoes-1-for-20-reverse-stock-split