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: 06 Apr 2018
At a glance
- Drugs Fluocinolone acetonide (Primary)
- Indications Posterior uveitis
- Focus Registrational; Therapeutic Use
- Sponsors EyePoint Pharmaceuticals
- 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.
- 07 Feb 2018 Results at 12 months published in the pSivida media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History