Aldeyra Therapeutics to Present Phase 3 ALLEVIATE Trial Results in Allergic Conjunctivitis at American Academy of Ophthalmology 2019 Annual Meeting
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
“The immune-modulating profile exhibited by both concentrations of reproxalap is distinct from standard-of-care antihistamine therapy,” said
Aldeyra plans to initiate a second Phase 3 trial of topical ocular reproxalap in patients with allergic conjunctivitis following feedback from the
Poster presentation details:
The ALLEVIATE Phase 3 Allergic Conjunctivitis Clinical Trial of Topical Ocular Reproxalap, a Novel RASP Inhibitor
PD45 Cornea, External Disease ePoster Discussion
Monday, October 14, 2019, 1:15 PM to 1:45 PM (PT)
ePoster Lounge, Station 3
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Aldeyra Therapeutics, Inc.
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