pSivida‘s (NSDQ:PSDV) announced that it won German approval for its Iluvien drug-device combination, launching immediately and touting the 1st commercial treatment this month in Deutschland on a patient with diabetic macular edema.
The company, which licenses the Iluvien technology to Alimera Sciences (NSDQ:ALIM), ran into regulatory problems in the U.S. when its FAME study failed to pass the FDA criteria for approval. The 2 companies plan to re-submit a new drug application to the FDA.
The product is already on the shelves in the U.K. and FDA approval would land pSivida a $25 million milestone payment from Alimera, which already pays pSivida 20% of net profits from European sales of Iluvien.
"We are very pleased Iluvien is now available in Germany as well as for privately insured and private pay patients in the U.K.," said CEO Paul Ashton in prepared remarks. "We are also very pleased by Alimera’s resubmission of the NDA for Iluvien to the FDA and the recently announced PDUFA goal date of October 17, 2013."