A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Trial Profile

A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2017

At a glance

  • Drugs Fluocinolone acetonide (Primary)
  • Indications Intermediate uveitis; Panuveitis; Posterior uveitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors pSivida
  • Most Recent Events

    • 11 Sep 2017 According to a pSivida media release, the company is expecting to submit an NDA to the US FDA by late December or early January 2018.
    • 10 Jul 2017 According to an Alimera Sciences media release, company anticipates that data from this and other phase III study will support the approval of ILUVIEN for the treatment of posterior uveitis in Europe, the Middle East and Africa.
    • 22 Jun 2017 According to pSivida Corp. media release, based on the data from this and other Phase III trial (see profile 248911) the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market Durasert 3-year treatment for posterior segment uveitis in the European Union (EU).
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