Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top