Brief: Aldeyra Therapeutics Receives Complete Response Letter From The U.S. Food And Drug Administration For The Reproxalap New Drug Application For The Treatment Of Signs And Symptoms Of Dry Eye Disease
17/03/2026 12:31
March 17 (Reuters) - Aldeyra Therapeutics Inc ALDX.O: ALDEYRA THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM THE U.S. FOOD AND DRUG ADMINISTRATION FOR THE REPROXALAP NEW DRUG APPLICATION FOR THE TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE ALDEYRA THERAPEUTICS INC - FDA STATES REPROXALAP NDA FAILED TO DEMONSTRATE EFFICACY FOR DRY EYE DISEASE ALDEYRA THERAPEUTICS INC - NO SAFETY OR MANUFACTURING CONCERNS IDENTIFIED IN REPROXALAP NDA REVIEW ALDEYRA THERAPEUTICS INC - FDA RECOMMENDS EXPLORING TRIAL FAILURES; NO ADDITIONAL TRIALS REQUESTED FOR REPROXALAP ALDEYRA THERAPEUTICS INC - TO REQUEST TYPE A MEETING WITH FDA WITHIN 30 DAYS PER PDUFA GOALS Source text: ID:nBw3JYPjta Further company coverage: ALDX.O ((Reuters.Briefs@thomsonreuters.com;))
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