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Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease
LEXINGTON, Mass., June 17, 2025--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. Per FDA agreement, the only new
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"LEXINGTON, Mass., June 17, 2025--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. Per FDA agreement, the only new clinical data included in the resubmitted NDA were from the recently completed dry eye chamber trial, which achieved the primary endpoint.","length":656,"tagName":"p"},{"type":"text","content":""Consistent with a number of clinical trials that suggest the potential of reproxalap to rapidly improve the symptoms of dry eye disease, we believe the clinical trial results included in the resubmission announced today are robust," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Based on the lack of notable baseline differences across treatment arms and the highly statistically significant achievement of the prespecified primary endpoint in favor of reproxalap over vehicle, in conjunction with recent FDA discussions, we believe that previous concerns raised by the FDA have been addressed."","length":656,"tagName":"p"},{"type":"text","content":"In April 2025, Aldeyra received a Complete Response Letter from the FDA that stated that potential methodological issues in a previously completed dry eye chamber trial, including a baseline difference across treatment arms, may have affected the interpretation of the results; the letter stated that an additional symptom trial would be required for resubmission. In May 2025, Aldeyra announced the achievement of the primary endpoint (P=0.002) in a Phase 3 randomized, double‑masked, vehicle‑controlled dry eye chamber trial that assessed the activity of reproxalap in reducing ocular discomfort, an FDA‑accepted symptom of dry eye disease. No notable differences in baseline scores across treatment arms were observed in the clinical trial, and no safety concerns were identified. Consistent with prior clinical trials, the most common adverse event was mild and transient instillation site discomfort, which most commonly lasted less than one...