Phase III, multicentre, randomized, double-blind trial for the treatment of non-infectious posterior segment uveitis.
Phase of Trial: Phase III
Latest Information Update: 25 Apr 2017
At a glance
- Drugs Sirolimus (Primary)
- Indications Posterior uveitis
- Focus Registrational; Therapeutic Use
- Acronyms SAKURA Study 2
- Sponsors Santen Incorporated
- 25 Apr 2017 According to a Santen Pharmaceutical media release, based on the on the the data from the SAKURA Program (SAKURA-1 and SAKURA-2 studies) the FDA has accepted the NDA of Sirolimus and as per the Prescription Drug User Fee Act (PDUFA) set an action date of 24 December 2017 to complete its review.
- 28 Nov 2016 Primary endpoint has not been met. (Vitreous haze (A vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale)), according to a Santen Pharmaceutical media release.
- 28 Nov 2016 Results published in a Santen Pharmaceutical media release.