Aldeyra Hits Primary Goal in Reproxalap Phase 3 Dry Eye Trial; NDA Resubmission Planned

Aldeyra Therapeutics, Inc., a biotechnology firm based in Lexington, Massachusetts, has announced a significant achievement in the advancement of treatments for dry eye disease. The company's 0.25% reproxalap ophthalmic solution has successfully met the primary endpoint in a Phase 3 clinical trial. This trial, which was randomized, double-masked, and vehicle-controlled, evaluated the effectiveness of reproxalap in a dry eye chamber setting.

The key focus of the trial was to measure the symptom of ocular discomfort, a common issue in dry eye disease patients. Results demonstrated that reproxalap was statistically more effective than the placebo in reducing ocular discomfort. Specifically, the reproxalap group exhibited a notable decrease in discomfort scores between 80 to 100 minutes after entering the chamber, with a statistically significant mean difference.

The trial's results are particularly important for Aldeyra as they could address previous concerns raised by the U.S. Food and Drug Administration (FDA). In April 2025, the FDA had issued a Complete Response Letter regarding a previous New Drug Application (NDA). This letter highlighted certain issues in a prior trial, such as differences in baseline scores across treatment arms, which may have influenced the interpretation of the results. With no significant baseline differences in the recent trial, Aldeyra is optimistic that the new data will satisfy the FDA's feedback.

Aldeyra plans to engage with the FDA in a Type A meeting to discuss the trial outcomes and anticipates resubmitting the NDA by mid-2025. The company expects the review period to last approximately six months. Additionally, Aldeyra completed a dry eye field trial that supports reproxalap, though it did not reach statistical significance. This data is expected to be part of the NDA resubmission.

Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, emphasized the promising potential of reproxalap in quickly alleviating ocular discomfort. He highlighted the trial's robust results in favor of reproxalap and expressed confidence in addressing the FDA's concerns outlined in the previous response letter.

Reproxalap has emerged as a pioneering investigational drug showcasing both acute and chronic efficacy in reducing dry eye symptoms. It is also the first candidate demonstrating acute activity in alleviating ocular redness exacerbations. Across multiple trials, reproxalap has shown no safety issues or treatment-related discontinuations. The most frequently reported adverse effect was mild and temporary discomfort at the application site.

To date, over 2,900 patients have participated in clinical studies involving reproxalap, demonstrating its extensive evaluation and safety profile. Aldeyra is committed to advancing this promising candidate towards market approval, hopeful that it will offer significant relief to individuals suffering from dry eye disease.