In an investigational allergen chamber, a novel RASP inhibitor reproxalap (Aldeyra Therapeutics) demonstrated statistical superiority to vehicle across the typical symptoms and signs of allergic conjunctivitis, according to a poster presented at AAO 2020 Virtual.
Researchers conducted a phase 2 clinical trial to evaluate the prophylactic and treatment activity of reproxalap, a novel reactive aldehyde species inhibitor, in an allergen chamber. The allergen chamber enables a controlled, environmental allergen exposure that mimic real-world exposure to airborne allergens. In the randomized, double-masked, crossover phase 2 trial of reproxalap ophthalmic solution (0.25% and 0.5%) and vehicle, symptoms, and ocular redness of 70 allergic conjunctivitis participants were assessed over 3.5 hours in an allergen chamber of aerosolized ragweed pollen (3,500 grains/m3). Test article was administered bilaterally 5 minutes before chamber entry and at 90 minutes after chamber entry.
Results demonstrated that reproxalap was safe and well-tolerated in the 66 participants who completed all visits. Relative to vehicle, both concentrations of reproxalap demonstrated statistically significant and clinically relevant improvements in ocular itching, tearing, and redness over the duration of exposure in the chamber. Prophylactic and treatment effects of the drug were demonstrated, they reported. The 0/25% concentration of reproxalap was advanced to the phase 3 allergen chamber trial.
Reference
Brady T, et al. A phase 2 clinical trial of topical ocular reproxalap, a novel RASP inhibitor, in an allergen chamber model of allergic conjunctivitis. Presented at: AAO 2020 Virtual. [Session: PO0103].
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