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Reproxalap FDA Approval Status

FDA Approved: No
Generic name: reproxalap
Company: Aldeyra Therapeutics, Inc.
Treatment for: Dry Eye Disease

Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species) in development for the treatment of signs and symptoms of dry eye disease.

Development timeline for reproxalap

DateArticle
May  8, 2024Aldeyra Therapeutics Enrolls First Patient in Phase 3 Clinical Trial Designed to Enable Potential Resubmission of New Drug Application of Reproxalap in Dry Eye Disease
Mar 28, 2024Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
Nov 27, 2023Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Dry Eye Disease
Jun 15, 2023Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis
Feb  7, 2023Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease
Nov 29, 2022Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease
May  1, 2018Aldeyra Therapeutics Presents Dry Eye Disease Phase 2a Clinical Trial Results for Reproxalap at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting

Further information

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