Enrollment completed in phase III INVIGORATE-2 clinical trial in allergic conjunctivitis
Aldeyra Therapeutics, Inc. announced completion of enrollment in the Phase III INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis
The randomized, double-masked, crossover, vehicle-controlled Phase III clinical trial enrolled 131 seasonal allergic conjunctivitis patients who were evaluated for 3.5 hours in an allergen chamber designed to simulate real-world pollen exposure. Consistent with pivotal trials of approved allergic conjunctivitis products, the primary endpoint of INVIGORATE-2 is patient-reported ocular itching. Top-line results from the trial are expected in the first half of 2023.
The protocol of INVIGORATE-2 is substantially identical to that of the Phase III INVIGORATE clinical trial and a Phase II clinical trial, both of which achieved the ocular itching endpoint (P<0.001).
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