BioCentury
ARTICLE | Clinical News

Iluvien fluocinolone acetonide intravitreal implant: Completed Phase III enrollment

April 6, 2015 7:00 AM UTC

pSivida completed enrollment of 120 patients in a double-blind, sham-controlled, international Phase III trial evaluating 0.18 mg intravitreal Iluvien. The trial targeted 120 patients with recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis but will allow an additional 10 patients to enroll this month. Iluvien is approved in the U.S. and 15 European countries for diabetic macular edema (DME). pSivida plans to submit a regulatory application to FDA for the uveitis indication in late 2016 or early 2017. ...