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Ocular表示FDA认为第三阶段研究适合支持NDA

2024-08-07 23:31

  • Shares of Ocular Therapeutix (NASDAQ:OCUL) rose 6% Wednesday after the company said the FDA has determined that its Phase 3 SOL-R clinical trial is appropriate as a registrational study to support potential approval of Axpaxli as a treatment for wet age-related macular degeneration, or wet AMD.
  • Ocular said it intends to use the SOL-R and SOL-1 studies as the basis for a New Drug Application for Axpaxli for wet AMD, according to a statement.
  • Earlier Wednesday, Ocular reported a flat year-over-year Q2 net loss of $0.26 per share on higher revenue of $16M. The company added that it had $459.7M in cash and equivalents as of the end of June, which should fund operations into 2028.

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