Reproxalap achieves ocular redness primary endpoint in phase 2 dry eye trial
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Reproxalap achieved the primary endpoint of improved ocular redness in patients with dry eye disease in a phase 2 clinical trial, according to a press release from Aldeyra Therapeutics.
In the randomized, double-masked, vehicle-controlled trial, 80 patients received 0.25% reproxalap ophthalmic solution, and 78 patients received vehicle ophthalmic solution.
Ocular redness scores were significantly lower in the reproxalap group than the vehicle group (P = .016). After the first dose, Schirmer’s test scores favored reproxalap, with the difference between the groups approaching significance. Mean visual analog scale ocular dryness and ocular discomfort scores were also lower in those treated with reproxalap, but the differences were not significant.
“Ocular redness may be the only dry eye disease sign that is of importance to patients, and the reduction in redness observed in this trial following reproxalap treatment potentially represents a major advance for the chronic treatment of dry eye disease,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
Two phase 3 clinical trials investigating reproxalap are ongoing, with data from the trials expected to be released by the end of the year.