A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Trial Profile

A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) 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: 25 Jul 2018

At a glance

  • Drugs Fluocinolone acetonide (Primary)
  • Indications Posterior uveitis
  • Focus Registrational; Therapeutic Use
  • Sponsors EyePoint Pharmaceuticals
  • Most Recent Events

    • 25 Jul 2018 According to an EyePoint Pharmaceuticals media release, data from this trial were presented at the 36th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS).
    • 02 Apr 2018 Planned End Date changed from 1 Dec 2019 to 1 Jun 2020.
    • 19 Mar 2018 According to a pSivida media release, the company has announced that its New Drug Application (NDA) for Durasert three-year treatment for posterior segment uveitis has been accepted by the U.S. Food and Drug Administration (FDA) for substantive review. The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018.
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