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Today, Aldeyra Therapeutics announced that its investigational therapy reproxalap eye drops reached the primary endpoint and all secondary endpoints in the Phase 3 clinical trial INVIGORATE for the treatment of patients with allergic conjunctivitis, significantly reducing itching, redness and tearing of the eyes caused by allergies.
Allergic conjunctivitis
Allergic conjunctivitisThere are currently more than 1 billion patients with allergic conjunctivitis in the world.
Due to the increase in global temperature, the number of seasonal pollen has soared, leading to the increasing prevalence of allergic conjunctivitis and dry eye.
Reproxalap
ReproxalapReproxalap is a new type of small molecule immunomodulatory covalent RASP inhibitor, which can reduce the level of RASP and achieve the effect of inhibiting inflammation and relieving symptoms.
INVIGORATE test
INVIGORATE testThe previously completed Phase 3 ALLEVIATE trial has confirmed the safety and effectiveness of two different concentrations of reproxalap eye drops (0.
In the randomized, double-blind, vehicle-controlled phase 3 clinical trial INVIGORATE, patients with allergic conjunctivitis were challenged with allergens after receiving reproxalap or placebo treatment.
▲Reproxalap reached the primary efficacy endpoint of relieving eye itching (picture source: reference [2])
Reproxalap eye drops have been administered to more than 1,200 patients in 14 clinical trials.
Aldeyra Therapeutics plans to discuss INVIGORATE's trial results and potential new drug application (NDA) submission with the US FDA in the second half of 2021.
Reference materials:
[1] Aldeyra Therapeutics Achieves Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE Clinical Trial of Reproxalap in Allergic Conjunctivitis.
[2] https://ir.
Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.