Outlook Therapeutics(US:OTLK)2021-10-01 19:40ONS-5010 Overview - ONS-5010 (bevacizumab-vikg) targets the $13.1 billion global ophthalmic anti-VEGF market[6] - The company aims to submit a U S FDA BLA in calendar Q1 2022 for ONS-5010, with a launch anticipated in Q1 2023[6] - Over 50% of the U S market is available for conversion to ONS-5010, representing billions in yearly sales[7] Clinical Trial Results - In the NORSE TWO trial, 41% of ONS-5010 subjects experienced a gain of at least 15 letters in BCVA at 11 months, compared to 23% in the ranibizumab group (p = 0 0052)[52] - The mean change in BVCA through 11 months in the NORSE TWO trial was 11 2 letters for ONS-5010 versus 5 8 letters for ranibizumab (p = 0 0043)[52] - In NORSE TWO, 73 5% of subjects in the ONS-5010 group experienced at least one treatment-emergent adverse event (TEAE), compared to 76 5% in the ranibizumab group[53] Market and Competitive Landscape - Unapproved bevacizumab represents 50% of U S wet AMD market injections[17] - The DR/DME market is expected to be impacted by biosimilars and lower-cost alternatives with a -2 2% CAGR, while the wAMD market is expected to grow due to new entrants and earlier diagnosis, with a 4 1% CAGR[15] - A survey indicated that 84% of retinal specialists (U S + EU) expressed interest or high interest in an FDA-approved ophthalmic bevacizumab to treat wet AMD, DME, and BRVO[27]