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Aldeyra Therapeutics Stock Is Trading Higher On Acing Allergic Conjunctivitis Study With Reproxalap

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  • Aldeyra Therapeutics Inc (NASDAQ: ALDX) has announced positive top-line results from the Phase 3 INVIGORATE trial evaluating 0.25% reproxalap, in patients with allergic conjunctivitis.

  • 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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