Aldeyra Therapeutics to Present Phase 3 ALLEVIATE Trial Results in Allergic Conjunctivitis at American Academy of Ophthalmology 2019 Annual Meeting

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it will host an ePoster presentation and discussion of the company’s ALLEVIATE Phase 3 clinical trial of reproxalap in patients with allergic conjunctivitis at the American Academy of Ophthalmology 2019 Annual Meeting, which takes place October 12-15, 2019 at the Moscone Center in San Francisco, California.

In the ALLEVIATE trial, 318 patients were topically challenged with seasonal allergen and randomized to 0.25% or 0.5% reproxalap topical ophthalmic solution, or vehicle ophthalmic solution. The trial achieved the primary endpoint of reduction in patient-reported ocular itching relative to vehicle, as assessed by area under the ocular itch score curve. Two-point responder rates and rates of complete resolution of itch in patients treated with 0.25% and 0.5% reproxalap were statistically greater than that of vehicle-treated patients, confirming the clinical relevance of the improvement of drug over vehicle in the primary endpoint.

Topical ocular reproxalap, a novel Reactive Aldehyde Species (RASP) inhibitor, has been administered to over 800 patients across ten completed clinical trials with no observed safety or tolerability concerns. In June 2019, Aldeyra announced results of topical ocular reproxalap in an allergen chamber trial, which demonstrated that ocular itching and redness in reproxalap-treated patients were statistically lower than that of vehicle-treated patients.

“The immune-modulating profile exhibited by both concentrations of reproxalap is distinct from standard-of-care antihistamine therapy,” said Todd Brady, M.D., Ph.D., President and CEO of Aldeyra. “Reproxalap represents a fundamentally different mechanism of action that we believe has the potential to be the first new approach in allergic conjunctivitis in more than 40 years.”

Aldeyra plans to initiate a second Phase 3 trial of topical ocular reproxalap in patients with allergic conjunctivitis following feedback from the U.S. Food and Drug Administration, which is expected in the fourth quarter of this year.

Poster presentation details:

Title:		The ALLEVIATE Phase 3 Allergic Conjunctivitis Clinical Trial of Topical Ocular Reproxalap, a Novel RASP Inhibitor
Session:		PD45 Cornea, External Disease ePoster Discussion