Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

Phase 3 Completed 129 enrolled EyePoint Pharmaceuticals, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Timeline

Start: 2013-08-02
Primary completion: 2018-03-26
Completion: 2018-03-26

Outcome

Met primary endpoint

paper cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001) PMID 32624244 ↗

Publications

Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology. 2020 Oct;127(10):1395-1404. doi: 10.1016/j.ophtha.2020.04.001. Epub 2020 Apr 17.

Drugs

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