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The 95-subject trial achieved statistical significance for the primary endpoint and all secondary endpoints.
The primary efficacy endpoint was the change from baseline in subject-reported ocular itching score after allergen chamber entry. The key secondary endpoint was the change from baseline in ocular redness 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 across all 11 prespecified primary endpoint comparisons (p<0.0001 for each comparison).
The reproxalap-treated patients demonstrated a statistically significant reduction in ocular redness over the duration of the allergen chamber.
The company is also conducting TRANQUILITY trials in dry eye disease, with data expected in the second half of 2021.
Aldeyra plans to meet with the FDA in the second half of 2021 to discuss the INVIGORATE results and the potential submission of a marketing application.
Reproxalap is a novel small-molecule immune-modulating covalent inhibitor of RASP elevated in ocular and systemic inflammatory disease.
The company will host a conference call at 8:00 a.m. ET today.
Price Action: ALDX shares are up 31.9% at $14.65 in premarket trading on the last check Tuesday.
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