pSivida Reports Iluvien Receives Marketing Authorization in Two More EU Countries

pSivida Corp.,  a leader in the development of sustained release drug delivery products for treating eye diseases, has announced that Finland and Luxembourg have granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. This brings the total number of EU countries in which Iluvien has been approved to 15, with two EU approvals still pending.

Iluvien has also been approved in the US, where sales are scheduled to commence in the first quarter of 2015. It is indicated for DME patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure, a broader indication than that approved for Europe.

“We are pleased with the marketing approvals for Iluvient in the EU, and we very much look forward to its introduction in the US. We are entitled to 20% of net profits from sales of Iluvie by its licensee on a country-by-country, quarter-by-quarter basis,” said Dr Paul Ashton, President and CEO of pSivida. “Iluvien provides retinal doctors a new treatment to help patients with DME, which can often cause significant vision loss and greatly affect quality of life for patients.”