Aldeyra Therapeutics, Inc. announced the clinical development plan intended to enable resubmission of a New Drug Application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease to the U.S. Food and Drug Administration (FDA). Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024. Contingent on positive results from the planned clinical trial, NDA resubmission is expected in the second half of 2024.

Based on FDA guidance, the planned review period for the potential NDA resub mission is expected to be six months. The design and statistical powering for the proposed trial are derived from four previously completed dry eye chamber clinical trials with reproxalap. Based on the data from the previous clinical trials, when analyzed with the planned trial design and statistical plan, ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003).

The planned clinical trial is expected to be more than 90% powered to detect a difference between treatment groups. A clinical trial at a different dry eye chamber, in addition to a traditional six-week field clinical trial, are expected to be conducted in parallel with the planned clinical trial as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment. The mechanism of action of reproxalap has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.

Reproxalap has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.