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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-2

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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-2

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2022

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At a glance

  • Drugs Timbetasin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ARISE-2
  • Sponsors ReGenTree

Most Recent Events

  • 02 Mar 2022 According to a ReGenTree Media Release, the pre-BLA (Biologics License Application) meeting was held by the Office of New Drugs/Office of Specialty Medicine in CDER and the Department of Ophthalmology/Office of Specialty Medicine, including specialists from statistics, safety, pharmacology, CMC, GCP and RA at FDA on 28 Feb 2022 to discuss a potential BLA submission for RGN-259 for dry eye syndrome.
  • 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to a ReGenTree Media Release, based on recent reclassification of RGN-259 to a Biologics License Application and the draft guidance for dry eye from the FDA, the company has started discussions with regulatory consulting firms to explore the prospects of a pre-BLA meeting with the FDA using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.

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