FDA accepts Aldeyra's reproxalap NDA resubmission for dry eye disease; PDUFA Dec 16, 2025

Aldeyra Therapeutics, Inc.

FDA accepted for review the resubmitted NDA for topical ocular reproxalap, a first-in-class candidate for dry eye disease.
PDUFA target action date set for December 16, 2025.
Resubmission includes a single clinical trial that met primary endpoint of reducing ocular discomfort vs vehicle control.
Reproxalap is the only dry eye investigational therapy to show acute activity reducing ocular discomfort and redness in pivotal trials simulating disease flares.

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