Shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) experienced a significant increase of 8.64% in pre-market trading on Thursday. This surge came as a biotechnology company announced promising outcomes from the Phase 3 INVIGORATE-2 Clinical Trial of their investigational new drug, reproxalap ophthalmic solution, for allergic conjunctivitis patients.
The clinical trial, which enrolled 131 individuals, utilized a randomized, double-masked, vehicle-controlled, two-way crossover design allergen chamber. The primary objective was to assess the change in patient-reported ocular itching score over a span of 11 timepoints, ranging from 110 to 210 minutes after allergen exposure. The secondary endpoint focused on evaluating the change in ocular redness throughout the 3.5-hour duration of allergen exposure.
The results of the trial were highly encouraging. Patients treated with reproxalap reported a statistically significant reduction in ocular itching score compared to those treated with the vehicle across all 11 specified timepoints in the allergen chamber. In addition, reproxalap-treated patients showed a significant decrease in ocular redness compared to baseline. The trial also demonstrated positive outcomes for other secondary endpoints, such as ocular tearing and overall ocular severity.
Reproxalap ophthalmic solution has been administered to over 2,400 patients in various clinical trials. Consistent with previous experiences, the INVIGORATE-2 Trial revealed no safety concerns, with only mild and transient instillation site irritation reported as the most common adverse event. Notably, no patients discontinued the trial due to adverse events, and the overwhelming majority of participants completed the study.
Aldeyra Therapeutics has submitted a New Drug Application (NDA) for reproxalap’s approval in the treatment of dry eye disease, which is currently under review by the U.S. Food and Drug Administration. The Prescription Drug User Fee Act (PDUFA) date for reproxalap’s potential approval is set for November 23, 2023.
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