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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2018

At a glance

  • Drugs Thymosin-beta-4 (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ARISE-2
  • Sponsors ReGenTree
  • Most Recent Events

    • 13 Apr 2018 Planned End Date changed from 1 Nov 2017 to 1 Nov 2018.
    • 13 Apr 2018 Planned primary completion date changed from 1 Nov 2017 to 1 Nov 2018.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top