This article is part of MPR’s coverage of the American Academy of Ophthalmology 2019 Meeting, taking place in San Francisco, CA. Our staff will report on medical research related to eye disorders, conducted by experts in the field. Check back regularly for more news from AAO 2019.
SAN FRANCISCO – Findings from the phase 3 ALLEVIATE trial demonstrated that reproxalap 0.25% and 0.5% ophthalmic solution achieved the primary and key secondary end points in patients with allergic conjunctivitis, presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, held October 12-15, 2019 in San Francisco, California.
The multicenter, randomized, double-masked, parallel-group, vehicle-controlled, phase 3 trial assessed the safety and efficacy of reproxalap ophthalmic solution compared to a vehicle in 318 adult patients with allergic conjunctivitis. Patients were randomized 1:1:1 to either reproxalap 0.25%, reproxalap 0.5%, or vehicle ophthalmic solution. The primary end point was ocular itch score (0 to 4 scale) area under the curve from 10 to 60 minutes after allergen challenge, as measured by the Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale. Secondary end points included the proportion of two-point ocular itch score responders, and conjunctival redness, as measured by the Ora Calibra Ocular Hyperemia Scale.
Results showed a statistically significant reduction in ocular itching for reproxalap 0.25% and 0.5% compared to vehicle (P <.0001 and P =.0025, respectively). Additionally, the two-point responder rates for reproxalap 0.25% and 0.5% were statistically greater than the vehicle (P =.0005 and P =.0169, respectively). Regarding safety, the most common treatment-emergent adverse event was mild, transient instillation site irritation with no other observed safety or tolerability concerns.
Reproxalap (Aldeyra Therapeutics) is an immune-modulating reactive aldehyde species (RASP) inhibitor that works by covalently binding to free aldehydes and diminishing excessive RASP levels, which are generally elevated in ocular and systemic inflammatory disease. Reproxalap offers a new mechanism for reducing ocular inflammation in allergic conjunctivitis, dry eye disease, and anterior uveitis. The 0.25% ophthalmic solution is advancing for subsequent phase 3 trials for the treatment of dry eye disease and allergic conjunctivitis.
Clark D, et al. The ALLEVIATE Phase 3 Allergic Conjunctivitis Clinical Trial of Topical Ocular Reproxalap, a Novel RASP Inhibitor. Poster presented at American Academy of Ophthalmology 2019 Meeting; October 12-15, 2019; San Francisco, CA. Abstract PO095.