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Phase 3 trial planned for reproxalap in allergic conjunctivitis
Aldeyra Therapeutics will initiate the phase 3 INVIGORATE trial of topical ocular reproxalap following positive results from an allergen chamber clinical methods trial, according to a press release.
Expanded results of the double-masked, randomized, vehicle-controlled, crossover allergen chamber clinical methods trial found highly statistically significant activity relative to vehicle in all symptoms and signs, the release said. Ocular itching and tearing, reported by patients, as well as ocular redness, were recorded at various intervals over 3.5 hours of ragweed exposure during the trial.
Patients treated with 0.25% or 0.5% reproxalap had statistically significant reductions in ocular itching, redness and tearing compared with those treated with vehicle (all P < .0001).
“We believe that the allergic conjunctivitis results released today, in aggregate, represent the first rigorous demonstration of activity of a late-stage, novel immune-modulating agent in an allergen chamber,” David J. Clark, MD, MRCP, chief medical officer of Aldeyra, said in the release. “The allergen chamber is an innovative and demanding assessment that combines real-world applicability with controlled allergen exposure. The results from the trial indicated distinct prophylactic and treatment activity of reproxalap in reducing all of the primary signs and symptoms of allergic conjunctivitis: ocular itching, redness and tearing.”
Based on these results, Aldeyra has reached an agreement with the FDA on the design and primary endpoint of the phase 3 trial.
With a planned initiation date in the first half of 2020, the INVIGORATE trial will evaluate 0.25% reproxalap vs. vehicle in an allergen chamber, and the primary endpoint will be a statistically significant reduction in ocular itching at the majority of 11 time points.