Aldeyra Therapeutics announced the last patient has completed dosing in the ALLEVIATE Phase 3 clinical trial of topical ocular reproxalap in patients with allergic conjunctivitis.

"We look forward to announcing the results of the ALLEVIATE clinical trial in early 2019 as the first of three Phase 3 readouts expected next year," said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Affecting approximately 20% of the population worldwide, allergic conjunctivitis is a common disease that can cause persistently disturbing symptoms, and is often associated with dry eye disease. Reproxalap's novel mechanism has the potential to be uniquely effective in allergic conjunctivitis, and may offer increased durability of activity relative to standard of care."

The ALLEVIATE trial is a multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial that enrolled over 300 allergic conjunctivitis patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a conjunctival allergen challenge model of acute allergic conjunctivitis.  The primary outcome measure will be patient-reported ocular itching.

Results from the Phase 3 clinical trial are expected to be announced in early 2019.

Allergic conjunctivitis is a common disease that affects 20% or more of the population worldwide.  The disease is mediated in part by RASP (Reactive Aldehyde Species) and is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling, and redness. Allergic conjunctivitis is often associated with dry eye disease. Antihistamines are commonly prescribed for allergic conjunctivitis, but compliance is limited by ocular dryness and lack of effect on non-histaminic pathways involving RASP.

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