Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment

Core Article Summary - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma) as a treatment option for wet age-related macular degeneration (wet AMD) [1][3] - LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK, with 10 years of market exclusivity [3][4] - Outlook Therapeutics, the developer of LYTENAVA™, has achieved regulatory approval in the EU and UK for this treatment [2][4] Product Details - LYTENAVA™ (bevacizumab gamma) is an ophthalmic formulation of bevacizumab specifically designed for treating wet AMD [4][6] - The product works by binding to vascular endothelial growth factor (VEGF), preventing its interaction with receptors on endothelial cells, thereby reducing cell proliferation and new blood vessel formation in the retina [6] - In the US, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is currently under investigation in a non-inferiority study for wet AMD treatment [5][7] Company Strategy - Outlook Therapeutics is focused on the development and commercialization of LYTENAVA™ for retina diseases, particularly wet AMD [7] - The company plans to commercially launch LYTENAVA™ in the EU and UK in the first half of 2025 [7] - In the US, if the ongoing study is successful, Outlook Therapeutics may resubmit a Biologics License Application (BLA) to the FDA [7] Regulatory Status - LYTENAVA™ has received Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [4][7] - The product is currently investigational in the US, with potential to become the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [5][7]