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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2017

At a glance

  • Drugs Sirolimus (Primary)
  • Indications Posterior uveitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SAKURA Study 1
  • 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.
    • 15 Dec 2016 Status changed from active, no longer recruiting to completed.
    • 28 Nov 2016 According to a Santen Pharmaceutical media release, based on the on the totality of the data from the SAKURA Program (SAKURA-1 and SAKURA-2 studies) the company plans to file a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2017.
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