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

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

Completed
Phase of Trial: Phase II/III

Latest Information Update: 09 Apr 2018

At a glance

  • Drugs Thymosin-beta-4 (Primary)
  • Indications Dry eyes
  • Focus Therapeutic Use
  • Acronyms ARISE-1
  • Sponsors ReGenTree
  • Most Recent Events

    • 09 Apr 2018 According to a RegeneRx Biopharmaceuticals media release, the results from ARISE-1 and ARISE-2 studies has been discussed with the US FDA for the further development of the subbmission of NDA of RGN-259, a novel drug candidate to treat dry eye syndrome. Company has announced the outcome of this discussions, that, for NDA subbmission the FDA requires additional data from the planned efficacy phase 3 study ( ARISE-3), which would be conducted in a larger patient population.
    • 09 May 2017 Results from this trial will be presented at the 2017 ARVO meeting, according to a RegeneRX Biopharmaceuticals media release.
    • 17 Aug 2016 Status changed from active, no longer recruiting to completed.
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