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

Core Viewpoint - Outlook Therapeutics has received FDA acknowledgment for the resubmission of the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD), with a PDUFA goal date set for August 27, 2025 [1][2] Group 1: Company Developments - The BLA resubmission is based on the efficacy and safety data from the NORSE EIGHT clinical trial and additional chemistry, manufacturing, and controls (CMC) information requested by the FDA [2] - If approved, ONS-5010 will be marketed as LYTENAVA™ in the United States and is expected to receive 12 years of regulatory exclusivity [1][2] - The company is preparing for the commercial launch of LYTENAVA™ in the EU and UK, anticipated in the second quarter of 2025 [6] Group 2: Product Information - ONS-5010 / LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in the EU and UK for wet AMD [3][6] - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that targets all isoforms of human vascular endothelial growth factor (VEGF), inhibiting its biological activity and reducing retinal issues associated with wet AMD [5] Group 3: Regulatory Context - The FDA has classified the BLA as a Class 2 review, which entails a six-month review period from the resubmission date [1][2] - The company believes that the complete data set from the NORSE EIGHT trial, along with additional CMC information, provides sufficient evidence for the approval of the BLA in the United States [2]