Outlook Therapeutics® Streamlines Operations

Core Viewpoint - Outlook Therapeutics is focusing on the commercial launch of LYTENAVA™ (bevacizumab gamma) for wet age-related macular degeneration (wet AMD) in the EU and UK, while also preparing to resubmit its Biologics License Application (BLA) for ONS-5010 in the U.S. following a strategic review to streamline operations and reduce costs [1][2]. Company Initiatives - The management team has implemented initiatives to streamline the organization, reduce operating expenses, and preserve capital, aiming to maximize efforts for the commercial launch of LYTENAVA™ [1][2]. - A 23% reduction in workforce has been announced, which is expected to save approximately $1.4 million annually, excluding the costs associated with the workforce reduction [2]. Regulatory Approvals - LYTENAVA™ has received Marketing Authorization from the European Commission in the EU and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, making it the first authorized ophthalmic formulation of bevacizumab for treating wet AMD [2][5]. - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ as a treatment option for wet AMD [2]. Clinical Trials and Future Plans - The company plans to resubmit its BLA for ONS-5010 in the first quarter of 2025, pending the full efficacy and safety results from the NORSE EIGHT clinical trial expected in January 2025 [2][6]. - Preliminary data from the NORSE EIGHT trial indicated an improvement in vision and a favorable safety profile for ONS-5010, despite not meeting the pre-specified non-inferiority endpoint [2][6]. Product Overview - ONS-5010/LYTENAVA™ is a recombinant humanized monoclonal antibody designed to treat wet AMD by neutralizing vascular endothelial growth factor (VEGF) [4][5]. - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [6].