Aldeyra Therapeutics announced on June 17, 2025, the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap. This investigational new drug candidate is for the treatment of signs and symptoms of dry eye disease. This marks the third time Aldeyra has submitted the NDA for reproxalap.
Per agreement with the FDA, the resubmitted NDA included only new clinical data from a recently completed dry eye chamber trial, which achieved its primary endpoint with statistical significance (P=0.002). Aldeyra believes that the robust clinical trial results, characterized by a lack of notable baseline differences across treatment arms, address the methodological concerns raised by the FDA in its April 2025 Complete Response Letter.
The Prescription Drug User Fee Act (PDUFA) target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission and completion of the submission review within six months. This resubmission is a crucial step in Aldeyra's efforts to secure regulatory approval for reproxalap, which has been studied in over 2,900 patients with no observed safety concerns.
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