Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Core Insights - The article highlights the first positive reimbursement decision for LYTENAVA™ (bevacizumab gamma) by NICE, marking a significant milestone for Outlook Therapeutics in the treatment of wet AMD [1][2][4] Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing LYTENAVA™ for retinal diseases, particularly wet AMD [9] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab approved in the EU and UK for treating wet AMD, with an initial 10 years of market exclusivity [1][9] Regulatory Approval and Market Launch - NICE has recommended LYTENAVA™ as a treatment option for wet AMD, applicable in England and Wales, following its marketing authorization by the UK Medicines and Healthcare products Regulatory Agency (MHRA) [2][3] - The commercial launch of LYTENAVA™ in the UK is anticipated in the first half of 2025, with plans for subsequent launches in EU countries [2][9] Clinical Evidence - The NICE recommendation was based on results from three completed registration clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE, along with supporting studies [4] Strategic Collaborations - Outlook Therapeutics has entered a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™, focusing on market access and distribution efficiency [5]