Early onset and broad activity of reproxalap in a randomized, double-masked, vehicle-controlled Phase 2b trial in dry eye disease
American Journal of Ophthalmology Feb 04, 2021
Clark D, Tauber J, Sheppard J, et al. - Researchers conducted this randomized, double-masked, vehicle-controlled Phase 2b trial to evaluate the activity of reproxalap, a novel reactive aldehyde species (RASP) inhibitor, relative to vehicle in patients with a dry eye disease (DED). For this trial, 300 patients with DED were randomly assigned 1:1:1 at multiple US sites to get 0.1% topical ocular reproxalap, 0.25% topical ocular reproxalap, or vehicle. For the signs and symptoms of DED, a dose response was observed. In DED patients over 12 weeks of therapy, the novel RASP inhibitor reproxalap demonstrated rapid, broad, and clinically relevant symptomatic control, combined with statistically significant improvement over vehicle in DED signs as shown by fluorescein staining. The findings are the first vehicle-controlled proof of RASP inhibition's therapeutic potential for mitigating the signs and symptoms of dry eye disease.
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