Aldeyra Therapeutics Completes Enrollment in Phase 3 INVIGORATE-2 Clinical Trial in Allergic Conjunctivitis

Top-Line Results Expected in the First Half of 2023

LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis.

“Today, millions of allergic conjunctivitis patients rely on therapies that may not provide sufficient relief or cannot be used chronically due to serious side effects,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Reproxalap, which has demonstrated rapid and durable improvement in the symptoms and signs of allergic conjunctivitis across a number of clinical trials, could signify the first new therapeutic mechanism of action in decades for patients suffering from this persistently disturbing condition.”

The randomized, double-masked, crossover, vehicle-controlled Phase 3 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 3 INVIGORATE clinical trial and a Phase 2 clinical trial,1 both of which achieved the ocular itching endpoint (P