pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a company based in Massachusetts, USA, has announced the receipt of approval from the FDA for its sustained release fluocinolone acetonide intravitreal implant (Iluvien) for the treatment of diabetic macular edema (DME). Achievement of the regulatory milestone entitles pSivida to a $25 million payment from its licensee, Alimera Sciences Inc., in addition to a 20% share of the future net profits from sales of the drug in the U.S., schedule to being in Q1 2015. The treatment will be 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). According to the company, a single injection of the Iluvien micro-insert provides sustained treatment of DME for 36 months. pSivida’s licensee and lead commercial sponsor, Alimera Sciences, Inc., stated that Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.
pSivida Corporation receives $25M milestone payment from licensee Alimera Sciences Inc. following FDA approval of Iluvien
- by swdadmin