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# Aldeyra Dry Eye NDA Accepted for Review
- URL: https://www.fdaweb.com/aldeyra-dry-eye-nda-accepted-for-review/
- Published: 2024-11-18T12:00:00.000Z
- Updated: 2026-09-14T14:47:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158208

FDA has accepted for review an Aldeyra Therapeutics NDA for reproxalap, a first-in-class investigational topical new drug candidate for treating signs and symptoms of dry eye disease. The agency has set a user fee review action target date of 4/2/2025.

Reproxalap is described as a small-molecule modulator of reactive aldehyde species, which the company says are elevated in ocular and systemic inflammatory diseases. “Reproxalap has been studied in more than 2,500 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials,” the company says.