pSivida Corp. (NASDAQ: PSDV) today announced that the U.S. Food and Drug Administration (FDA) has approved ILUVIEN® for the treatment of diabetic macular edema (DME). It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). A single injection of the ILUVIEN micro-insert provides sustained treatment of DME for 36 months. Approximately 560,000 people in the U.S. are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries. ILUVIEN is expected to be commercially available in the U.S. in early 2015.
FDA approval of ILUVIEN entitles pSivida to a $25 million milestone from its licensee Alimera Sciences (Nasdaq: ALIM). pSivida will also be entitled to 20% of the net profits from sales of ILUVIEN in the U.S.