Aldeyra Therapeutics Introduces phase 3 INVIGORATE-2 trial of reproxalap to treat allergic conjunctivitis meets primary and secondary endpoints

ldeyra Therapeutics, Inc. (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, announced positive top-line results from the phase 3 INVIGORATE-2 clinical trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.

“Consistent with the results of the phase 3 INVIGORATE Trial and in conjunction with a number of successful phase 2 and phase 3 clinical trials in dry eye disease, achievement of the primary endpoint and all secondary endpoints in INVIGORATE-2 supports the potential of reproxalap as a treatment for inflammatory diseases of the ocular surface,” stated Todd C. Brady, M.D., Ph.D., president and CEO of Aldeyra.

“We believe that the rapid-onset activity of reproxalap evidenced in the INVIGORATE clinical trials may offer hope to allergic conjunctivitis patients who are today not adequately treated, and also to dry eye disease patients, up to 50% of whom suffer from ocular allergy.” Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction across all 11 prespecified primary endpoint comparisons (P<0.0001 for each comparison) from 110 to 210 minutes in the allergen chamber.

The reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (P=0.004) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber. “The co-morbidity of allergic conjunctivitis and dry eye disease poses diagnostic and treatment challenges to patients and healthcare providers,” stated William B. Trattler, MD., vice chair of research and associate professor of ophthalmology at Herbert Wertheim College of Medicine. “For patients who have had a poor response to over-the-counter ocular allergy medications, the data announced today may suggest that reproxalap could satisfy a substantial unmet need in patients who suffer from allergic conjunctivitis and dry eye disease.” Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases.