Aldeyra Therapeutics announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for the treatment of dry eye disease (DED). Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of DED, the company said in a press release.

In addition, the company said there were no safety signals observed in the clinical trial, and reproxalap was observed to be well tolerated. Consistent with prior clinical trials, the most commonly reported adverse event was mild and transient instillation site discomfort. No treatment-related discontinuations were reported.

In the Phase 3 clinical trial, patients were administered vehicle before and during exposure to a dry eye chamber in a manner that Aldeyra believes is consistent with the FDA’s DED draft guidance, the company said. Qualifying patients were subsequently randomized to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber. Of the 132 patients randomized, 66 patients received reproxalap and 66 patients received vehicle. The primary endpoint was ocular discomfort, an FDA-accepted symptom of DED, from 80 to 100 minutes in the chamber.

According to the company, the dry eye chamber clinical trial was designed to satisfy the FDA’s New Drug Application resubmission requirement, identified in the previously received complete response letter, of “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.” Through the FDA Special Protocol Assessment process and additional comments, the FDA provided feedback on the clinical trial protocol and statistical plan.