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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2022

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At a glance

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

    • 01 Jun 2022 Results assessing Prevention of non-infectious uveitis of the posterior segment (NIU-PS) recurrence using 0.2 mug/day fluocinolone acetonide implant over 3 years, published in the Eye.
    • 23 Sep 2020 According to an Alimera Sciences media release, 3-year fellow eye subgroup analysis data from this trial will be featured during the EURETINA 2020 Virtual Congress.
    • 08 Sep 2020 According to an Alimera Sciences Scottish Medicines Consortium (SMC), after completing its assessment and review, has accepted (per label) ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).The decision came following a review of a cost-utility analysis for the prevention of relapse in recurrent non-infectious uveitis based on results from this study.
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