Core Viewpoint - Outlook Therapeutics, Inc. received a complete response letter (CRL) from the FDA regarding its biologics license application (BLA) for ONS-5010, indicating that the application cannot be approved in its current form for the treatment of wet age-related macular degeneration (wet AMD) [1][2][3] Group 1: FDA Response and Efficacy - The CRL cited a single deficiency related to a lack of substantial evidence of effectiveness, specifically noting that ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT trial [2] - The FDA recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010, while also acknowledging that the NORSE TWO trial met its primary endpoint for effectiveness [2] Group 2: Company Response and Future Plans - The company expressed disappointment with the FDA's decision but plans to meet with the FDA for further clarification on approval requirements for ONS-5010 [3] - Outlook Therapeutics remains committed to providing a safe and effective alternative to compounded Avastin and intends to continue expanding into additional markets in Europe [3] - LYTENAVA™ (bevacizumab gamma) has already received Marketing Authorization in the EU and the UK for the treatment of wet AMD and became commercially available in Germany and the UK in June 2025 [3][10] Group 3: Product Information - ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab specifically designed for the treatment of wet AMD [7][10] - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [11]