Reproxalap demonstrates safety in dry eye trial, with visual acuity improvement
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Treatment-related serious adverse events in ocular safety, the primary endpoints in a 12-month safety clinical trial of reproxalap for the treatment of dry eye disease, were not observed, according to an Aldeyra Therapeutics press release.
The trial included 447 patients with dry eye disease, with 299 receiving reproxalap and 148 receiving vehicle. The ocular safety events were consistent across both groups, and no safety concerns have been identified in more than 2,300 patients who have received reproxalap.
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In a post hoc analysis, reproxalap was superior to vehicle in improvement in distance visual acuity from baseline (P = .018), with logMAR in the reproxalap group improving approximately 37% (P < .0001).
This may represent the “first demonstration of improvement in distance visual acuity with a topically administered therapy,” according to the release.
“The lack of treatment-related serious adverse events over 12 months confirms the safety profile of reproxalap observed in prior clinical trials, and the potentially landmark evidence of improvement in visual acuity may differentiate reproxalap, if approved for sale, from other therapeutic options for the treatment of dry eye disease,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
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