Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter

Core Viewpoint - Outlook Therapeutics has submitted a Type A meeting request to the FDA following a Complete Response Letter regarding its Biologics License Application for ONS-5010/LYTENAVA™ for wet AMD treatment, citing a deficiency in evidence of effectiveness [1][2] Group 1: Regulatory Developments - The Complete Response Letter identified a single deficiency related to the lack of substantial evidence of effectiveness and recommended additional confirmatory evidence [2] - Outlook Therapeutics believes the FDA's determination is inconsistent with the totality of evidence submitted, including data from a well-controlled study [2] - The company conducted informal meetings with the FDA prior to submitting the Type A meeting request to discuss the CRL [2] Group 2: Clinical Evidence - ONS-5010 is supported by data from the NORSE TWO Phase 3 trial, which showed statistically significant improvements in visual acuity at 12 months, meeting its primary endpoint [3] - NORSE EIGHT, another Phase 3 study, provided additional evidence of efficacy despite not meeting its primary endpoint at 8 weeks, showing consistent gains in visual acuity [4] - A comprehensive package of confirmatory evidence was submitted, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition [5] Group 3: Safety and Manufacturing - ONS-5010 demonstrated a favorable safety profile, with ocular adverse reactions consistent with the control arm and no safety concerns raised by the FDA [6] - The product is supported by a fully domestic U.S. manufacturing supply chain, enhancing reliability and aligning with public health objectives [7] Group 4: Market Authorization - LYTENAVA™ has received Marketing Authorization in the EU and UK for wet AMD treatment and became commercially available in Germany and the UK in June 2025 [8] - It is the first authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK [9] - Outlook Therapeutics is exploring collaborations for commercial and distribution partnerships in additional European countries and beyond [8]