
Core Insights - Outlook Therapeutics, Inc. has received regulatory approval for LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in the EU and UK [2][4] - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ as a treatment option for wet AMD, marking it as the first authorized ophthalmic formulation of bevacizumab for this condition [3][4] - LYTENAVA™ is expected to have an initial market exclusivity of 10 years in the EU and UK [3] Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ for retinal diseases, including wet AMD [7] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the first half of 2025 [7] - In the United States, ONS-5010/LYTENAVA™ is currently investigational and undergoing a non-inferiority study for wet AMD [5][7] Product Details - LYTENAVA™ is a recombinant humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), reducing endothelial cell proliferation and vascular leakage in the retina [6] - The product has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK [4][7]