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
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
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History