A Common Disease with Suboptimal Therapy.
Allergic conjunctivitis has been estimated to affect 20 to 40% of the population worldwide, and is characterized by itchiness, redness, and excessive tear production. The disease is most often treated with a combination of anti-histamines (to diminish the allergic response) and adrenergic agonists (to diminish redness).
Current Allergic conjunctivitis treatment challenges.
Despite the availability of treatments for allergic conjunctivitis, a significant number of patients do not respond to anti-histamines, especially after the acute effects of the medication wear off. Many of these patients are then prescribed corticosteroids and other more potent drugs that lead to a variety of ocular toxicities. To make matters worse, the effects of adrenergic agonists lessen over time such that more and more drug is required to achieve the same amount of vasoconstriction (redness reduction).
The Allergic conjunctivitis treatment potential of ADX-102.
Aldehydes are thought to mediate part of the allergic response as well as ocular redness. By trapping aldehydes, ADX-102 represents a new therapeutic approach for the treatment of allergic conjunctivitis. In an animal model of ocular inflammation, ADX-102 was effective in diminishing ocular redness, and the effect of ADX-102 was equivalent to that observed with corticosteroids. In addition, ADX-102 has shown potent effects in the reduction of swelling in a skin model of allergy. Finally, ADX-102 leads to a down-regulation of key cytokines (protein mediators) of the allergic response.
In the first quarter of 2016, we announced positive data from our Phase IIa clinical trial of ADX-102 ophthalmic solution in patients with allergic conjunctivitis. Relative to baseline, the data indicated that ADX-102 clinically improved ocular itching and tearing scores after acute administration and after 14 days of dosing.