Aldeyra in FDA clinical plan for NDA resubmission of reproxalap for DED

Aldeyra Therapeutics announced the clinical development plan intended to enable resubmission of a New Drug Application NDA of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease to the U.S. Food and Drug Administration FDA . Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024. Contingent on positive results from the planned clinical trial, NDA resubmission is expected in the second half of 2024. Based on FDA guidance, the planned review period for the potential NDA resubmission is expected to be six months. “The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the symptoms of dry eye disease, a potentially debilitating and increasingly pervasive condition that affects millions of patients worldwide,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.