Phase III, multicentre, randomized, double-blind trial for the treatment of non-infectious posterior segment uveitis.

Trial Profile

Phase III, multicentre, randomized, double-blind trial for the treatment of non-infectious posterior segment uveitis.

Recruiting
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
  • Most Recent Events

    • 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.
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