BioCentury
ARTICLE | Company News

FDA approves Iluvien for DME

September 26, 2014 4:18 PM UTC

FDA approved an NDA from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) for Iluvien fluocinolone acetonide (FA) intravitreal implant to treat diabetic macular edema in patients who have been previously treated with corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Alimera plans to launch Iluvien in the U.S. in 1Q15.

Alimera has exclusive, worldwide rights to Iluvien from pSivida under a 2008 deal. The approval triggered a $25 million milestone payment to pSivida, which is also eligible for a 20% royalty on U.S. sales. ...