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news.Aldeyra Therapeutics has reported that the results from a phase IIa clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant and sustained clinical effects, such as reduction of ocular itching and tearing.
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NS2 is an aldehyde-binding small molecule based on a platform technology that centers on trapping aldehydes, which are toxic and pro-inflammatory mediators of several diseases.
It lowers aldehyde load and may mitigate over inflammation and address diseases where aldehyde metabolism is impaired, such as various inborn errors of metabolism.
The randomized, parallel-group, single-center, double-masked, vehicle-controlled trial was carried out in 100 healthy men and women with at least a two-year history of allergic conjunctivitis to grass, tree, or ragweed pollen.
The subjects were randomized in equal groups for treatment with NS2 or vehicle. The clinical endpoints included patient assessment of ocular itching and tearing, two inflammation-associated symptoms of allergic conjunctivitis.
Aldeyra said NS2 was well tolerated and there were no safety concerns during the study.
Following single-dose and multiple-dose administration, statistically significant differences were demonstrated for ocular itching and ocular tearing between NS2 and vehicle.
Aldeyra Therapeutics president and CEO Todd Brady said: "To our knowledge, the data from this clinical trial represent the first example of clinical efficacy of an aldehyde trap in human disease.
"We are thrilled with the outcome of this trial and believe that the results suggest important insight into the physiology of inflammation and further applicability of aldehyde trapping in the treatment of inflammatory disease."
NS2 is also being studied in patients with noninfectious anterior uveitis and Sjögren-Larsson syndrome.
Image: Allergic conjunctivitis is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye). Photo: courtesy of jscreationzs/FreeDigitalPhotos.net.