Primary endpoint achieved in phase III dry eye disease chamber trial of reproxalap; NDA resubmission planned - Aldeyra

Aldeyra Therapeutics, Inc. announced the achievement of the primary endpoint in a Phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap (n=58) was statistically significantly superior to vehicle (n=58) on ocular discomfort symptom score (0‑100) from 80 to 100 minutes after chamber entry (LS mean difference [95% confidence interval] ‑6.5 [‑10.5, ‑2.5], P=0.002).

Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the FDA feedback in a Complete Response Letter received in April 2025 in response to the prior New Drug Application (NDA). The Complete Response Letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results, including a baseline difference across treatment arms. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid‑2025, and the review period is expected to be six months. A recently completed dry eye disease field trial, which was numerically supportive of reproxalap and consistent with prior field trials, did not reach statistical significance, and is expected to be submitted to the planned NDA resubmission as supportive.

“The dry eye chamber results announced today are representative of a number of clinical trials that highlight the potential rapid clinical effect of reproxalap on reducing ocular discomfort,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “With no notable baseline differences across treatment arms and highly statistically significant results in favor of reproxalap over vehicle, Aldeyra believes the data potentially address the FDA feedback in the Complete Response Letter received last month and we look forward to meeting with the FDA shortly.”

To Aldeyra’s knowledge, in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing exacerbation of ocular redness. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Consistent with prior clinical trials, the most commonly reported adverse event was mild and transient instillation site discomfort. Reproxalap has now been studied in over 2,900 patients.