Aldeyra Therapeutics Achieves Goals In Crossover Clinical Trial Of 0.25% Reproxalap Solution
(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX) announced Tuesday the achievement of the primary endpoints in a sequence-randomized, double-masked, vehicle-controlled crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease.
Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber and Schirmer test, a measure of tear production, after a single day of dosing.
The secondary endpoint of Schirmer test =10 mm responder analysis, which was multiplicity-controlled, was also achieved.
A pre-NDA meeting with the FDA has been scheduled for the third quarter of 2022.
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