Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Core Insights - The FDA has accepted the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), with a Prescription Drug User Fee Act (PDUFA) goal date set for December 31, 2025, marking a significant milestone for Outlook Therapeutics in bringing the first FDA-approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration (wet AMD) to the U.S. market [1][2][7] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases, particularly wet AMD [6] - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK, where it has received Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) [6] Product Details - ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab produced in the U.S. for treating wet AMD, which is currently under review in the U.S. [3][4][7] - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds to all isoforms of human vascular endothelial growth factor (VEGF), neutralizing its activity and reducing endothelial cell proliferation and vascular leakage in the retina [5]