Outlook Therapeutics(US:OTLK) 美股IPO·2026-01-01 04:13Core Viewpoint - Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ONS-5010/LYTENAVA™, indicating that the application for treating wet age-related macular degeneration (wAMD) cannot be approved in its current form [2][3]. Group 1: FDA Response and Company Position - The FDA's CRL stated that the additional data provided in the BLA did not alter the previous review conclusion, despite a well-controlled study demonstrating efficacy. The FDA recommended submitting confirmatory evidence to support the application but did not specify what type of evidence would be acceptable [3][8]. - The CEO of Outlook Therapeutics expressed disappointment with the FDA's decision but reaffirmed the company's commitment to obtaining approval in the U.S. and emphasized the clinical need and commercial potential for a specifically formulated bevacizumab product for intravitreal use [6][11]. Group 2: Clinical Trial Data - The resubmission of the BLA for ONS-5010 was based on the complete dataset from the NORSE clinical trial program, which included successful results from the NORSE TWO pivotal trial and additional safety and efficacy data from other NORSE trials [8]. - The NORSE TWO trial demonstrated significant efficacy, and the company believes that the complete dataset supports the BLA for approval in the U.S. [8]. Group 3: Market Expansion and Product Launch - LYTENAVA™ has received marketing authorization in the EU and the UK for treating wAMD, with plans to launch in Germany and the UK by June 2025 [11][19]. - The product is positioned as a cost-effective, first-line treatment option for healthcare professionals and patients, with potential gross peak sales exceeding $300 million across Germany and the UK, representing over 50% of the total opportunity in Western Europe [19][20].