pSivida has announced the availability of the sustained release pharmaceutical product indicated for the treatment of chronic diabetic macular edema (DME), Iluvien, in Germany.
Alimera Sciences, pSivida's licensee, has reported the treatment of first patient following the commercial launch in the region.
pSivida president and chief executive officer Dr. Paul Ashton said Iluvien is now available in Germany in addition to privately insured and private pay patients in the UK.
"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," Ashton added.
"We will be entitled to 20% of net profits, as defined, in each of Germany and the U.K. from sales of ILUVIEN by Alimera. If the FDA approves ILUVIEN, we would also be entitled to an additional $25 million milestone payment from Alimera as well as 20% of net profits on any sales in the U.S. by Alimera."
Iluvien (sustained release fluocinolone acetonide) is an injectable, non-erodible, intravitreal implant for the treatment of DME.
DME is a common complication of diabetic retinopathy and is caused by fluid build-up in the central vision portion of the retina.
