Fluocinolone acetonide intravitreal implant regulatory update

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). ...