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 antihistamines to diminish the allergic response.
Current Allergic conjunctivitis treatment challenges.
Despite the availability of treatments for allergic conjunctivitis, a significant number of patients do not respond to antihistamines, especially after the acute effects of the medication wear off. Many of these patients are then prescribed corticosteroids and other more potent drugs that may lead to a variety of ocular toxicities.
The Allergic conjunctivitis treatment potential of reproxalap.
Reactive Aldehyde Species (RASP) are thought to mediate part of the allergic response as well as ocular redness. By inhibiting RASP reproxalap represents a new therapeutic approach for the treatment of allergic conjunctivitis. In an animal model of ocular inflammation, reproxalap was effective in diminishing ocular redness, and the effect of reproxalap was equivalent to that observed with corticosteroids. In addition, reproxalap has shown potent effects in the reduction of swelling in a skin model of allergy. Finally, reproxalap leads to a down-regulation of key cytokines (protein mediators) of the allergic response.
We announced positive data from our Phase 2a and Phase 2b clinical trials of reproxalap ophthalmic solution in allergic conjunctivitis. The results indicate that reproxalap clinically improved ocular itching scores in patients with allergic conjunctivitis in an allergen challenge model.
In March 2019, Aldeyra announced positive phase 3 results from the ALLEVIATE Trial in Allergic Conjunctivitis. Reproxalap achieved its primary endpoint of a statistically significant reduction in ocular itch score compared to vehicle. Positive results were also seen on the key secondary endpoint of two-point responder rates when compared to vehicle. In preparation for subsequent clinical testing, Aldeyra is conducting clinical method development studies to assess the feasibility of measuring ocular itching induced by environmental exposure to allergen. In the second half of 2019, Aldeyra plans to meet with regulatory authorities to discuss the ALLEVIATE results and remaining clinical requirements for a potential submission of a New Drug Application to the U.S. Food and Drug Administration.