Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010

Core Viewpoint - Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010 to the FDA, aiming for approval of its ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) [1][2] Company Overview - Outlook Therapeutics is a biopharmaceutical company 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 wet AMD treatment [6] Product Details - ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab produced in the U.S. for wet AMD [3][7] - If approved in the U.S., it would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [7] - LYTENAVA™ has received centralized Marketing Authorization from the European Commission and the MHRA in the UK for wet AMD treatment [3][4] Regulatory Progress - The resubmission of the BLA is seen as a significant step in addressing issues raised in the Complete Response Letter (CRL) received in August 2025 [2] - The company is accelerating its commercial efforts in Europe while preparing for potential near-term U.S. approval [2]