Aldeyra Therapeutics Announces Publication of Phase 2 Clinical Trial of Reproxalap in Allergen Chamber Model
Aldeyra Therapeutics announced that results from the randomized, double-masked, vehicle-controlled, crossover phase 2 clinical trial of reproxalap in an allergen chamber model have been published in the peer-reviewed journal Clinical Ophthalmology.1 Reproxalap, an investigational new drug, is a first-in-class reactive aldehyde species (RASP) modulator that has been shown to mitigate inflammation in patients with allergic conjunctivitis and other eye diseases.
“Although allergic conjunctivitis affects more than 20% of the U.S. population2 and up to 60% of patients require medication other than topical antihistamines,3 a new mechanistic pharmacologic treatment approach has not been available for decades,” Todd C. Brady, MD, PhD, President and Chief Executive Officer of Aldeyra, said in a company news release. “This phase 2 allergen chamber trial suggests that treatment with reproxalap could lead to rapid and durable improvement in the symptoms and signs of allergic conjunctivitis.”
A total of 70 adult patients with a history of moderate to severe allergic conjunctivitis for two or more years, a positive skin test to ragweed pollen, and chamber-induced ocular itching and redness scores of 2.5 or more and 2 or more (both scales range from 0 to 4), respectively, were randomized 1:1:1 to one of three sequences of treatment with 0.5% reproxalap, 0.25% reproxalap, and vehicle. Test article was administered bilaterally just before and at 90 minutes after entering an allergen chamber, during which patients were exposed to aerosolized ragweed pollen (3500 grains/m3) for 3.5 hours. Symptoms and conjunctival redness were assessed approximately every 10 minutes after entering the chamber and over an hour after chamber exit. Compared to vehicle, treatment with either concentration of reproxalap led to rapid, statistically significant improvement in patient-reported ocular itching and tearing and investigator-assessed ocular redness. Improvement in signs and symptoms persisted over the entire chamber and all post-chamber time points.
About Reproxalap
Reproxalap, an investigational new drug, is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap’s mechanism of action has been supported by the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology.
References
1 Clark D, Karpecki P, Salapatek AM, Sheppard JD, Brady TC. Reproxalap Improves Signs and Symptoms of Allergic Conjunctivitis in an Allergen Chamber: A Real-World Model of Allergen Exposure. Clin Ophthalmol. 2022;16:15-23; Originally published by and used with permission from Dove Medical Press Ltd. https://doi.org/10.2147/OPTH.S345324
2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988–1994. J Allergy Clin Immunol. 2010;126(4):778–783. doi:10.1016/j.jaci.2010.06.050
3 Leonardi A, Piliego F, Castegnaro A, et al. Allergic conjunctivitis: a cross-sectional study. Clin Exp Allergy. 2015;45(6):1118–1125. doi:10.1111/cea.12536
4 The American Academy of Allergy, Asthma & Immunology (AAAAI), Allergic Conjunctivitis Defined
5 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J. Bron (2004) Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437