Reproxalap ophthalmic solution achieves statistical significance for primary and all secondary endpoints in phase III INVIGORATE clinical trial in allergic conjunctivitis- - Aldeyra Therapeutics.

Aldeyra Therapeutics, Inc. announced positive top-line results from the Phase III INVIGORATE Clinical Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints. The randomized, double-masked, vehicle-controlled, two-way crossover design allergen chamber Phase III INVIGORATE Trial enrolled 95 allergic conjunctivitis patients. The primary efficacy endpoint was change from baseline in subject-reported ocular itching score on a 0-4 point scale over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry. The key secondary endpoint was change from baseline in ocular redness on a 0-4 point scale over the duration of the allergen chamber (approximately 3.5 hours). Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction over all 11 prespecified primary endpoint comparisons (p<0.0001 for each comparison) from 110 to 210 minutes in the allergen chamber. the reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (p><0.0001) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber. statistical significance was also achieved for the two secondary endpoints of change from baseline in patient-reported ocular tearing score on a 0?3 point scale over the duration of the allergen chamber (p><0.0001) and change from baseline in total ocular severity score (11-point composite of the itching, redness, and tearing scores) over the duration of the allergen chamber (p><0.0001). in the phase iii alleviate trial , 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular itching over one hour following direct topical conjunctival allergen challenge. in aldeyra’s phase ii allergen chamber trial, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular itching and investigator-assessed ocular redness. in the run-in cohort of the phase iii tranquility trial in dry eye disease patients, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular dryness scores and investigator-assessed ocular redness in the dry eye chamber. the primary endpoint of the phase iii tranquility and tranquility-2 trials is ocular redness over the duration of the chamber. results from the tranquility trials in dry eye disease are expected in the second half of 2021. reproxalap ophthalmic solution has now been administered to more than 1,200 patients across 14 clinical trials. consistent with prior clinical experience with reproxalap, there were no observed safety or tolerability concerns in the invigorate trial and no observed adverse events other than mild and transient instillation site discomfort typical of many prescribed topical ophthalmic medications for anterior segment inflammation. aldeyra plans to meet with the fda in the second half of 2021 to discuss the invigorate results and the potential submission of a new drug application.>