Aldeyra’s Reproxalap meets primary endpoint in Phase III clinical trial

Reproxalap has demonstrated enhanced efficacy in alleviating symptoms of dry eye disease and reducing ocular redness. Aldeyra Therapeutics has achieved the primary endpoint in a Phase III trial for Reproxalap, an investigational drug also under development for allergic conjunctivitis.

In the Phase III randomized, double-masked, vehicle-controlled study, 0.25% Reproxalap ophthalmic solution significantly outperformed the vehicle in reducing ocular discomfort. The trial involved 132 patients exposed to a dry eye chamber, with half receiving Reproxalap and the other half a placebo. The primary endpoint assessed ocular discomfort between 80 and 100 minutes within the chamber.

The FDA has reviewed the trial protocol and statistical plan, and the positive results may facilitate a new drug application (NDA) resubmission later this year. Reproxalap, a first-in-class small-molecule modulator of RASP, has been well-tolerated in trials involving over 2,500 patients, with only mild, transient instillation site discomfort reported.