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John D Sheppard, Todd Brady, C. Stephen Foster, Kenneth J Mandell, Scott L Young; A Randomized, Comparator-Controlled Phase 2 Clinical Trial of ADX-102 Ophthalmic Solution in Noninfectious Anterior Uveitis. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1231.
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Aldehydes are pro-inflammatory mediators of allergic (TH2) and auto-immune (TH1) inflammation. ADX-102 is a novel aldehyde sequestering agent that represents a new anti-inflammatory drug class. There is evidence that prevention of toxic aldehyde formation and accumulation may diminish inflammation, fibrosis, and oxidative damage associated with ocular disease. ADX-102 has demonstrated positive Phase 2 results in allergic conjunctivitis. This Phase 2 clinical trial evaluated the safety and efficacy of ADX-102 in subjects with noninfectious anterior uveitis (NAU).
A randomized, multi-center, investigator-masked, comparator-controlled, parallel-group trial of 0.5% ADX-102 topical ophthalmic solution was conducted in 45 subjects with acute flares of NAU at 15 US sites. Subjects were randomized equally to 6 weeks of therapy with ADX-102 QID, 1% Prednisolone Acetate (PA, Pred Forte®, Allergan, Irvine, CA) QID (tapered), or a combination of ADX-102 QID and 1% PA BID (tapered). Efficacy was assessed by anterior chamber cell (ACC) counts and aqueous flare (AF).
Kaplan-Meier estimates of time to ACC treatment success, ACC grade reduction, AF treatment success, and AF grade reduction were similar across treatment groups and not statistically significantly different for any ADX-102 treatment group compared with PA alone. For ACC results, improvement to Grade 0 was seen in all treatment groups over the course of the study. At Week 8, the proportion of subjects with Grade 0 ACC was similar across groups, with 47%, 46%, and 44% in the ADX-102, PA, and combination groups, respectively. ACC and AF improved over time for all treatment groups. Post hoc inference testing showed that the Least Square mean change from Baseline in ACC grade for the ADX-102 and combination treatment groups was consistently greater than the PA group. Rescue rates did not vary significantly among treatment groups (20% in ADX-102, 38% in PA, 25% in the combination group).
These results suggest that ADX-102 treatment alone, or in combination with PA, was effective in the treatment of NAU with an efficacy profile similar to that of PA monotherapy in this clinical trial.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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