Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Core Insights - LYTENAVA™ (bevacizumab gamma) has received marketing authorization from the UK MHRA for the treatment of wet AMD, following similar approval from the European Commission [2][3][11] - The commercial launch of LYTENAVA™ in the EU and UK is anticipated in the first calendar quarter of 2025 [2][4][11] - Outlook Therapeutics has formed a strategic partnership with Cencora to support the commercial launches, providing comprehensive services including pharmacovigilance and market access support [5][6][11] Company Overview - Outlook Therapeutics is focused on the development and commercialization of ONS-5010/LYTENAVA™ for retinal diseases, specifically wet AMD [11] - LYTENAVA™ is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK [2][11] - In the United States, LYTENAVA™ is still under investigation and is being evaluated in a non-inferiority study for wet AMD [9][11] Regulatory Milestones - The marketing authorization application to the MHRA was completed under the new International Recognition Procedure, allowing reliance on the European Medicines Agency's positive opinion [3] - The approval from the MHRA is seen as a significant milestone for Outlook Therapeutics, paving the way for the expected commercial launch [5][4] Strategic Partnerships - Cencora will assist in the launch of LYTENAVA™ by providing services such as regulatory affairs, quality management, and distribution [6][12] - The collaboration aims to ensure timely and reliable access to LYTENAVA™ for healthcare providers and patients [6][12]