Phase 3 trial of reproxalap for dry eye disease treatment underway

The first patient has been enrolled in the phase 3 TRANQUILITY trial evaluating reproxalap for the treatment of patients with dry eye disease, according to a press release from Aldeyra Therapeutics.

The multicenter randomized, double-masked, parallel-design, vehicle-controlled clinical trial is designed to assess the safety and efficacy of reproxalap ophthalmic solution 0.25% vs. vehicle based on objective sign endpoints of dry eye. The analysis will include tear reactive aldehyde species (RASP) levels, Schirmer test and conjunctival redness. Results from a run-in cohort of 20 patients are expected this year and will be used to power the main cohort of the trial.

“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, president and CEO of Aldeyra, said in the release.