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A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye: ARISE-1

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Trial Profile

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye: ARISE-1

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2021

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At a glance

  • Drugs Timbetasin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ARISE-1
  • Sponsors ReGenTree

    • Most Recent Events

    • 13 May 2021 According to a ReGenTree Media Release, based on recent reclassification of RGN-259 to a Biologics License Application and the draft guidance for dry eye from the FDA, the company has started discussions with regulatory consulting firms to explore the prospects of a pre-BLA meeting with the FDA using these comprehensive data from ARISE-1, ARISE-2, and ARISE-3 studies. The company will proceed with a request for a pre-BLA meeting and future development steps will depend on the discussion results.
    • 13 May 2021 Pooled results from ARISE-1, ARISE-2, and ARISE-3 studies published in the ReGenTree Media Release.
    • 18 Mar 2021 According to a RegeneRx Biopharmaceuticals media release, the company look forward to completing the analyses, reporting results, and meeting with the FDA as soon as practicable.

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