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A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

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Trial Profile

A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 24 Dec 2025

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At a glance

  • Drugs Reproxalap (Primary)
  • Indications Dry eyes
  • Focus Therapeutic Use

Most Recent Events

  • 15 Dec 2025 According to an Aldeyra Therapeutics media release, the USFDA met with the company on 12 Dec 2025 to request the submission of Clinical Study Report (CSR) for the dry eye disease field trial of reproxalap, for which top-line results were announced on May 5, 2025. This CSR was considered a major amendment to the NDA by the FDA. Safety data from the field trial was also submitted to the NDA on August 21, 2025. The FDA notified that it will communicate proposed labeling requests after review.
  • 15 Dec 2025 According to an Aldeyra Therapeutics media release, the USFDA has extended the PDUFA target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.
  • 27 Nov 2023 According to an Aldeyra Therapeutics media release, the company intends to include in the potential NDA resubmission a draft label describing chronic and acute symptomatic benefit, in addition to acute reduction in ocular redness of reproxalap.

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