ARTICLE | Clinical News

Fluocinolone acetonide intravitreal implant regulatory update

September 29, 2014 7:00 AM UTC

FDA approved an NDA from Alimera for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Alimera plans to launch Iluvien in the U.S. in 1Q15. The approval triggered a $25 million milestone payment to pSivida from Alimera under a 2008 deal granting Alimera exclusive, worldwide rights to the injectable insert that delivers fluocinolone acetonide to the retina. pSivida is also eligible for 20% of net profits from the sales of Iluvien in the U.S. (see BioCentury, March 24, 2008). ...