Topical reproxalap reduces ocular itch in phase 3 allergic conjunctivitis trial

Topical reproxalap met its primary and secondary endpoints, reducing ocular itch in allergic conjunctivitis patients in a phase 3 trial, Aldeyra Therapeutics announced in a press release.

The double-masked, randomized, vehicle-controlled, multicenter, parallel-group ALLEVIATE trial studied the efficacy of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solution compared with vehicle.

As assessed by area under the ocular itch score curve, those treated with reproxalap had a statistically significant reduction in ocular itching (P < .0001 for 0.25% and P = .0025 for 0.5%).

Compared with vehicle-treated patients, those who received reproxalap had statistically significantly greater two-point responder rates (P = .0005 for 0.25% and P = .0169 for 0.5%).

“Consistent with positive results from five prior phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis,” Todd C. Brady, MD, PhD, Aldeyra president and CEO, said in the release. “Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current phase 3 program in dry eye disease.”