Aldeyra Completes Phase 3 Enrollment for Reproxalap in Dry Eye Disease

Aldeyra Therapeutics, Inc., a biotechnology firm based in Lexington, Massachusetts, has successfully completed enrollment for a Phase 3 clinical trial aimed at evaluating topical ocular 0.25% reproxalap, an investigational RASP modulator, for dry eye disease. This trial is crucial as it could potentially lead to the resubmission of a New Drug Application (NDA) for this treatment in the latter half of 2024.

A total of 132 participants have been recruited for the study, focusing on the primary endpoint of ocular discomfort. The enrollment phase began in May 2024. Previous clinical trials involving reproxalap have demonstrated a significant reduction in ocular discomfort compared to a placebo, with statistical analysis showing a high level of significance (p=0.0003).

Dr. Todd C. Brady, President and CEO of Aldeyra, emphasized the urgency and high demand for better dry eye disease treatments. He noted that the rapid enrollment reflects this unmet medical need. Dr. Brady also mentioned that the results from this clinical trial are anticipated by the third quarter of 2024. Should these results be favorable, Aldeyra plans to move forward with the NDA resubmission in the second half of 2024.

Aldeyra aims to include a draft label in the NDA resubmission that highlights both chronic and acute improvements in symptoms, as well as a reduction in ocular redness. If approved, this would be the first dry eye disease label incorporating clinical data assessed acutely in a dry eye chamber, and potentially the first to include reduction in ocular redness for a chronically administered drug. According to FDA guidelines, the review period for such a resubmission is expected to be around six months.

Additionally, Aldeyra is conducting another Phase 3 clinical trial of reproxalap in a different dry eye chamber and a traditional six-week field clinical trial. This dual approach is intended to account for the variability in clinical sites and environments, addressing the heterogeneity of the disease.

Aldeyra Therapeutics is dedicated to developing innovative therapies targeting immune-mediated and metabolic diseases. Unlike traditional approaches that focus on single protein targets, Aldeyra's strategy involves modulating protein systems to optimize multiple pathways simultaneously, thereby reducing toxicity. Their product pipeline includes several RASP modulators such as ADX-629, ADX-246, ADX-248, alongside reproxalap for treating dry eye disease and allergic conjunctivitis, and ADX-2191, an intravitreal methotrexate formulation aimed at treating retinitis pigmentosa.

This recent milestone underscores Aldeyra's commitment to advancing medical science and meeting patient needs through innovative therapeutic solutions. The company remains hopeful that reproxalap will meet the rigorous standards required for FDA approval, thus offering a new and effective treatment option for millions of people suffering from dry eye disease.