Outlook Therapeutics Provides Update on Type A Meeting with FDA

Core Viewpoint - Outlook Therapeutics, Inc. has completed a Type A Meeting with the FDA regarding the complete response letter for its biologics license application for ONS-5010, an investigational treatment for wet AMD, and plans to resubmit the application by the end of 2025 [1][2] Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to optimize the standard of care for retinal diseases [6] - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for the treatment of wet AMD [6] Product Information - ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab aimed at treating wet AMD and has received centralized Marketing Authorization in the EU and the UK [3][4] - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [7] Regulatory Discussion - The FDA meeting was described as productive, and the company is awaiting written minutes to finalize its plans for resubmission of the BLA [2] - The company remains committed to providing a safe and effective treatment for patients, physicians, and payors in the U.S. [2]