Aldeyra Announces First Patient Enrolled in the Phase 3 TRANQUILITY Trial of Reproxalap for the Treatment of Dry Eye Disease

Aldeyra Therapeutics announced enrollment of the first patient in the phase 3 TRANQUILITY trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease.

The multicenter randomized, double-masked, parallel design, vehicle-controlled clinical trial will assess the efficacy and safety of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume) following a single dose; and conjunctival redness in the dry eye chamber over 90 minutes. A run-in cohort of 20 patients is expected to be completed this year. Results from the run-in will be used to power the main cohort of the trial, and will confirm primary and secondary endpoints.

“Initiation of the phase 3 TRANQUILITY Trial, the first trial designed to characterize the acute effects of reproxalap on RASP and other objective signs of dry eye disease, marks another important step toward a planned NDA submission in dry eye disease by the end of 2021,” Todd C. Brady, MD, PhD, said in a company news release. “For the more than 30 million U.S. patients with dry eye disease, we believe that reproxalap has the potential to fulfill significant unmet need as a treatment with rapid onset of action and durable symptom control.”