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Aldeyra Therapeutics seeks US FDA approval after dry eye drug clears trial


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Aldeyra Therapeutics seeks US FDA approval after dry eye drug clears trial

Aldeyra Therapeutics Inc. will explore regulatory approval for reproxalap after the dry eye therapy reduced itching associated with allergic conjunctivitis in patients during a late-stage clinical trial.

The phase 3 clinical trial, called Alleviate, examined two doses of reproxalap topical ophthalmic solution in 318 patients with seasonal allergic conjunctivitis. The condition can cause dry eye, itching and redness after exposure to seasonal allergens. The trial's main goal was to reduce itching after exposure to an allergen, and the secondary goal was to determine patients' response to the therapy.

Reproxalap was found to be superior to standard antihistamine treatment in reducing inflammation and itching during the trial.

The therapy has previously been evaluated in five mid-stage clinical trials, but the Alleviate trial marks the first successful results in phase 3.

Aldeyra said in a March 26 press release that the positive results mean the Lexington, Mass.-based company will meet with the U.S. Food and Drug Administration in the second quarter to discuss submission of a new drug application for reproxalap.

Chief Medical Officer David Clark said that reproxalap could complement existing therapies for seasonal allergic conjunctivitis and allow patients to avoid progressing to corticosteroids, which he said can lead to ocular toxicity.

Reproxalap is also being developed for several other eye conditions, including dry eye disease.