Aldeyra Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for their investigational drug candidate, topical ocular reproxalap. This drug is designed to treat the signs and symptoms of dry eye disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. This acceptance follows an additional clinical trial that demonstrated the drug's efficacy in reducing ocular discomfort, meeting the FDA's requirements. Aldeyra looks forward to further discussions with the FDA during the review process, as reproxalap remains the only investigational therapy known to show acute activity in reducing ocular discomfort and redness in pivotal trials.
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