Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

Phase 3 Completed 153 enrolled EyePoint Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

Phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.

Timeline

Start: 2015-06-02
Primary completion: 2019-10-04
Completion: 2019-10-04

Outcome

Met primary endpoint

paper Fluocinolone acetonide implant-treated eyes had significantly reduced uveitis recurrence rates versus treated sham (46.5% vs. 75.0%, respectively; P = 0.001) PMID 38027419 ↗

Publications

Biswas J, Tyagi M, Agarwal M; PSV-FAI-005 Investigation Group. The 0.2-mug/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India. Ophthalmol Sci. 2023 Sep 16;4(1):100403. doi: 10.1016/j.xops.2023.100403. eCollection 2024 Jan-Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fluocinolone acetonide	Other / unclassified	0.18 mg	Intravitreal