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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2017

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At a glance

  • Drugs Sirolimus (Primary)
  • Indications Intermediate uveitis; Panuveitis; Posterior uveitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SAKURA Study 2
  • Sponsors Santen Inc

Most Recent Events

  • 21 Dec 2017 According to a Santen Pharmaceutical media release, the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for NDA of intravitreal (IVT) sirolimus (DE-109). The CRL indicates that the FDA is unable to approve the application in its present form and requests additional substantiating evidence to demonstrate efficacy of IVT sirolimus in the treatment of noninfectious uveitis of the posterior segment.
  • 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.

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