Positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc.
TORONTO, ON (PRWEB) MARCH 03, 2016
Inflamax Research Inc., a global full-service CRO specializing in inflammatory disease, announced positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc. (NASDAQ:ALDX). The study was conducted at Inflamax’s Toronto, Canada site and involved the use of the Conjunctival Allergen Provocation Test (CAPT) in patients with moderate to severe seasonal allergic conjunctivitis. The single-site study successfully randomized 100 subjects and used Inflamax’s innovative electronic diary system (ePDAT™) and electronic (paperless) data capture system (QDAQ™). The trial demonstrated statistically significance differences (p<0.05) between the NS2 treated group and the vehicle control group in ocular itching and tearing. NS2 was well-tolerated with no safety concerns. No serious adverse events were reported, and 98% of patients completed the trial.
“We are pleased to announce these positive and exciting results for Aldeyra’s NS2 ophthalmic solution and are impressed with this compound’s efficacy in allergic conjunctivitis,” said Dr. Holly Lorentz, Manager of Ocular Research at Inflamax Research.
Dr. Anne Marie Salapatek, President and Chief Scientific Officer at Inflamax Research, commented, “As a CRO with expertise in testing putative treatments for a variety of inflammatory diseases, Aldeyra’s unique aldehyde-trapping approach appears promising in ocular inflammatory diseases such as allergic conjunctivitis, and we look forward to continuing to work with Aldeyra on the clinical advancement of this novel aldehyde trap program.”
Allergic conjunctivitis is experienced by approximately 40% of the population and is thought to be mediated in part by pro-inflammatory aldehydes and leads to inflammation of various parts of the eye and eyelids, with corresponding symptoms of that often include itching, burning, tearing, sensitivity to light, redness, swelling, and mucus discharge.
Inflamax Research is a full-service, global CRO specializing in allergy, ocular and respiratory diseases, led by world-known, key-opinion leaders. Inflamax has a strong academic background and publishes extensively in peer-reviewed journals. Inflamax is experienced in the conduct of large single and multi-centre trials using their innovative fixed and mobile Environmental Exposure Chambers and direct instillation models from a study’s concept to protocol writing, site management, data management, and medical writing. Inflamax’s scientists and clinicians are well known to regulatory authorities and regularly participate in an advisory role.