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Paul J Gomes, Todd Brady, David Hollander, David Clark; A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group Phase 2b Allergic Conjunctivitis Clinical Trial of Topical Ocular ADX-102, a Novel Aldehyde Sequestering Agent. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5571.
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Pro-inflammatory aldehyde mediators potentiate allergic (TH2) and auto-immune (TH1) inflammation. ADX-102 is a novel aldehyde sequestering agent that represents a new anti-inflammatory drug class in development for the treatment of the immediate post-histaminic inflammatory phase of allergic conjunctivitis (AC) and other ocular inflammatory diseases. Post-histaminic AC, which begins 5 to 10 minutes following allergen exposure, is distinct from the acute histamine-mediated phase of AC that is partially prophylactically modulated by antihistamines. This Phase 2b clinical trial evaluated the safety and efficacy of 0.1% and 0.5% topical ocular ADX-102 in the Conjunctival Allergen Challenge (Ora-CAC®) model in subjects with allergic conjunctivitis.
A randomized, multi-center, double-masked, vehicle-controlled, parallel-group trial of 0.1% and 0.5% ADX-102 topical ophthalmic solution was conducted in 154 subjects with seasonal and perennial AC at 5 US sites. Subjects were randomized (1:1:1) to receive 0.1% ADX-102, 0.5% ADX-102, or vehicle drops bilaterally. Subjects were challenged ~60 minutes after dosing (1-hour duration CAC). Approximately 14 days later, subjects were dosed again and challenged ~10 minutes after dosing (10-minute onset CAC). Subject-reported ocular itching (range 0 to 4) was recorded from 5 to 60 minutes post-CAC.
Subject-reported ocular itching was statistically lower in the 0.5% ADX-102 group vs. the vehicle group 10 minutes (p=0.0164), 20 minutes (p=0.0379) and 30 minutes (p=0.0347) post-challenge at the 10-minute onset of action CAC visit. In seasonal allergic conjunctivitis patients, ocular itch score area under the curve 10 to 60 minutes post-challenge was statistically lower in the ADX-102 groups than the vehicle group (0.1% ADX-102 p=0.02 and 0.5% ADX-102 p=0.004). In a responder analysis (1-point improvement from baseline on the ocular itching scale), the responder odds ratio vs. vehicle was greater than 3 (p=0.02) for each of the ADX-102 groups. Both concentrations of ADX-102 were safe and well tolerated.
ADX-102 treatment was effective in the treatment of itching during the immediate post-histaminic inflammatory phase of AC. The durability of activity of ADX-102 over one-hour post-challenge in the CAC model exceeds that reported for antihistamines.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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