Aldeyra Therapeutics

  • Aldeyra Therapeutics: Reproxalap NDA PDUFA Date Extended for Dry Eye Treatment

    Aldeyra Therapeutics’ New Drug Application for dry eye treatment reproxalap has a new FDA target date of March 16, 2026, a three-month extension. This follows the FDA’s request for the Clinical Study Report of a recent field trial, which, while supportive, did not meet its primary endpoint. The FDA has indicated potential labeling requests and postmarketing requirements by February 16, 2026.

    5 days ago