Reproxalap is an investigational ophthalmic drug candidate being developed for dry eye disease and allergic conjunctivitis. Aldeyra describes it as a first-in-class small-molecule reactive aldehyde species (RASP) modulator with late-phase clinical experience. FDA issued a Complete Response Letter in April 2025 for the dry eye NDA resubmission, and the drug remained unapproved in that update.
The FDA issued a complete response letter rejecting Aldeyra Therapeutics' reproxalap for dry eye disease, marking the third rejection in three years due to inconsistent trial results and lack of substantial evidence of efficacy.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
