Aldeyra resubmits reproxalap NDA for dry eye disease after CRL, Phase 3 trial met primary endpoint

Aldeyra Therapeutics, Inc.

Resubmitted NDA to FDA for topical ocular reproxalap to treat signs and symptoms of dry eye disease.
Earlier CRL in April 2025 cited potential methodological issues; new Phase 3 dry eye chamber trial achieved primary endpoint (P=0.002).
No notable baseline differences across treatment arms; mild transient instillation site discomfort was most common AE.
PDUFA goal: FDA acceptance decision within 30 days, review completion within 6 months of submission.

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