Aldeyra Therapeutics announced that its 0.25% reproxalap ophthalmic solution achieved the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial. The trial assessed reproxalap as a treatment for dry eye disease, with reproxalap demonstrating statistically significant superiority to the vehicle for the primary endpoint of ocular discomfort (P=0.004).
Trial Design and Results
The Phase 3 clinical trial involved 132 randomized patients, with 66 receiving reproxalap and 66 receiving the vehicle. Patients were administered the vehicle before exposure to a dry eye chamber, followed by randomization to either reproxalap or the vehicle before a second chamber exposure. The primary endpoint was ocular discomfort, measured from 80 to 100 minutes in the chamber. This trial was designed to meet the FDA's requirement for an additional well-controlled study to demonstrate a positive effect on ocular symptoms of dry eye, as outlined in a previous complete response letter.
Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, stated, "To our knowledge, the results announced today represent the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease."
Safety and Tolerability
Reproxalap was observed to be well-tolerated in the clinical trial, with no significant safety signals reported. The most commonly reported adverse event, consistent with prior trials, was mild and transient instillation site discomfort. No treatment-related discontinuations were reported. Reproxalap has been studied in over 2,500 patients to date.
Reproxalap's Potential
Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory diseases. Aldeyra believes reproxalap is the first investigational drug with pivotal data supporting both acute and chronic activity in reducing dry eye symptoms, and the first for chronic administration with pivotal data supporting acute activity in reducing ocular redness.
Regulatory Outlook
The potential NDA resubmission for reproxalap is anticipated in 2024. Based on FDA guidance, the resubmission NDA review period is expected to be six months.
