Aldeyra Therapeutics, Inc. announced the completion of enrollment in a phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease. The trial is designed to enable potential resubmission of a dry eye disease new drug application (NDA) in the second half of 2024.
In the clinical trial, a total of 132 patients were enrolled to assess the primary endpoint of ocular discomfort. Initiation of enrollment was announced in May 2024. In four previously completed dry eye chamber clinical trials of reproxalap, when analyzed in aggregate with the trial design and statistical plan discussed with the U.S. Food and Drug Administration (FDA), ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003).
“We believe the rapid enrollment of the phase 3 clinical trial is consistent with the unmet medical need that exists for patients suffering from dry eye disease,” stated Todd C. Brady, MD, PhD, president and CEO of Aldeyra. “We anticipate receiving results from the clinical trial in the third quarter of 2024, and, contingent on positive results, we remain on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024.”
Aldeyra intends to include in the potential NDA resubmission a draft label for reproxalap describing chronic and acute improvement in symptoms and ocular redness. To Aldeyra’s knowledge, if approved, the draft label could represent the first dry eye disease label that incorporates clinical data assessed acutely in a dry eye chamber, and potentially the first dry eye disease label that includes reduction in ocular redness for a chronically administered drug. Per FDA guidance, the review period for the potential NDA resubmission is expected to be six months.
A phase 3 clinical trial of reproxalap at a different dry eye chamber, in addition to a traditional six-week field clinical trial, are being conducted in parallel as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment.