Realm Therapeutics has dosed the first patient in its Phase ll study of PR013 for the treatment of allergic conjunctivitis.
The multi-centre, double-blind, randomised trial is being conducted in the US, with top-line data expected by the second quarter of next year.
The trial aims to evaluate the effectiveness of PR013 topical ophthalmic solution compared with the vehicle for treatment of allergic conjunctivitis using a modified conjunctival allergen challenge model (Ora-CAC) in around 90 patients.
The Ora-CAC model has been the accepted standard used in the development of new treatments for allergic conjunctivitis in the US for the last three decades.
Realm Therapeutics CEO Alex Martin said: “Allergic conjunctivitis affects up to 40% of the US population but the current standards of care, steroids, and antihistamines have significant safety and efficacy shortcomings for patients.
“In preclinical models, PR013 has demonstrated similar efficacy to high-dose steroids in reducing the redness associated with allergic conjunctivitis, and in reducing itch from both histaminergic and non-histaminergic pathways.
“Harnessing Realm's proprietary high concentrations of hypochlorous acid, PR013 has the potential to be a novel, safe and effective treatment alternative for patients suffering from allergic conjunctivitis.”
Allergic conjunctivitis is an ophthalmic disease characterised by inflammation of the conjunctiva due to contact with airborne allergens.
The disease can be divided into two main categories, which are seasonal and perennial.
Seasonal allergic conjunctivitis is the most common form that follows a predictable course that coincides with seasonal increases in allergens.
Perennial allergic conjunctivitis is a chronic waxing and waning of reaction as a result of year-round allergen exposure.