Aldeyra Therapeutics has enrolled the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis.
"We are pleased to advance our allergic conjunctivitis program to Phase 3 clinical testing," said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "With clinically demonstrated post-histaminic activity, reproxalap could represent the first mechanistically differentiated product in decades for the treatment of allergic conjunctivitis, a chronic disease that affects approximately 100 million patients in the United States. We look forward to presenting the results of the trial in the second half of 2018 or early 2019."
The multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial is expected to enroll 300 allergic conjunctivitis patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a conjunctival allergen challenge model of acute allergic conjunctivitis. The primary outcome measure will be patient-reported ocular itching.
A clinical trial synopsis can be found on clinicaltrials.gov.