Aldeyra Therapeutics Inc ALDX reported topline results from the Phase 3 INVIGORATE-2 trial of 0.25% reproxalap ophthalmic solution, an investigational new drug, in patients with allergic conjunctivitis.
The trial achieved statistical significance for the primary endpoint and all secondary endpoints.
Also Read: Aldeyra Highlights 12-Month Safety Data Of Reproxalap In Dry Eye Disease Patients.
Relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction across all 11 prespecified primary endpoint comparisons from 110 to 210 minutes in the allergen chamber.
The reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to a vehicle 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 and change from baseline in total ocular severity score over the duration of the allergen chamber.
A New Drug Application of reproxalap for dry eye disease is under FDA review with a PDUFA date of November 23.
Price Action: ALDX shares are up 11% at $11.60 on the last check Thursday.
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