A pivotal phase 3 study of thymosin beta 4 (RGN 259) for Dry eyes : ARISE-3.
Phase of Trial: Phase III
Latest Information Update: 12 Apr 2018
At a glance
- Drugs Thymosin-beta-4 (Primary)
- Indications Dry eyes
- Focus Registrational; Therapeutic Use
- Acronyms ARISE-3
- Sponsors ReGenTree
- 12 Apr 2018 New trial record
- 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 Apr 2018 According to a RegeneRx Biopharmaceuticals media release, this trial is planned to initiate in 2018.