Outlook Therapeutics Requests Type A Meeting with FDA

Core Viewpoint - Outlook Therapeutics has submitted a Type A Meeting request to the FDA to discuss the complete response letter (CRL) regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational treatment for wet AMD [1][2]. Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg), an ophthalmic formulation of bevacizumab aimed at optimizing the standard of care for retinal diseases [7]. - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for the treatment of wet AMD [7]. Product Details - ONS-5010/LYTENAVA™ is an investigational product in the U.S. and has received centralized Marketing Authorization in the EU and the UK for treating wet AMD [4][5]. - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that targets human vascular endothelial growth factor (VEGF) to reduce endothelial cell proliferation and vascular leakage in the retina [6]. Regulatory Context - The FDA's CRL acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but requested additional confirmatory evidence of efficacy for ONS-5010 [2]. - The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA to address the deficiencies noted in the CRL [2][3].