Ocular Therapeutix Plans to File Eye Disease Drug Marketing Application in Q4

MT Newswires Live
09/15

Ocular Therapeutix (OCUL) said Tuesday that its marketing application for Axpaxli, its experimental treatment for wet age-related macular degeneration, remains on track for submission in Q4 following its meeting with the US Food and Drug Administration.

The company said the FDA meeting confirmed the planned marketing application package, which will include efficacy and safety data from a phase 3 trial, interim safety data from an ongoing trial, and other supporting evidence.

The application will be submitted under a pathway that could shorten the FDA review timeline by up to 60 days compared with the traditional submission, it added.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10