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Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient into the Phase 3 INVIGORATE Trial of topical ocular reproxalap in patients with allergic conjunctivitis.\n\n\n“Initiating enrollment in the INVIGORATE Trial moves us closer to our goal of providing allergic conjunctivitis patients with a new treatment option for one of the world’s most common ocular conditions,” said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Standard of care antihistamines are ineffective in nearly a quarter of all allergic conjunctivitis patients, many of whom require adjunct therapy, including corticosteroids, which cannot be used chronically due to toxicity. We believe that reproxalap may offer a durable and highly differentiated approach for the treatment of ocular allergy, a condition that is increasing in prevalence but has not benefited from the introduction of a novel therapeutic approach in decades.”\n\n\nThe INVIGORATE Trial, which will enroll approximately 120 patients, is a randomized, double-masked, crossover vehicle-controlled Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score.\n\n\nIn Aldeyra’s Phase 2 allergen chamber clinical methods trial, completed in March 2019, 0.25% reproxalap demonstrated highly statistically significant reductions from vehicle in ocular itching and redness.\n\n\nMore information about the INVIGORATE Trial is available on www.clinicaltrials.gov (NCT04207736).\n\n\nAbout Reproxalap\nReproxalap is a novel, small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease, and lead to activation of intracellular inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase...