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A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

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Trial Profile

A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Sirolimus (Primary)
  • Indications Intermediate uveitis; Panuveitis; Posterior uveitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SAKURA Study 1
  • Sponsors Santen Incorporated

    • Most Recent Events

    • 15 Mar 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 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.

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