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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

  • Drugs Reproxalap (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Sponsors Aldeyra Therapeutics

Most Recent Events

  • 05 May 2025 According to Aldeyra Therapeutics Media Release, Aldeyra believes the data potentially address the FDA feedback in the Complete Response Letter received last month and looking forward to meet with the FDA shortly
  • 05 May 2025 According to Aldeyra Therapeutics Media Release, Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid 2025, and the review period is expected to be six months.
  • 05 May 2025 According to Aldeyra Therapeutics Media Release, Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the U.S. Food and Drug Administration (FDA) feedback in a Complete Response Letter received in April 2025 in response to the prior New Drug Application (NDA).

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