pSivida Corp (PSDV) Reports ILUVIEN® For Chronic Diabetic Macular Edema Receives Marketing Authorization In Denmark, 9th EU Approval
8/1/2014 11:11:35 AM
WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ: PSDV, ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the Danish Health and Medicines Authority granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. ILUVIEN has now been approved in nine EU countries (Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and the United Kingdom), and is commercially available in the United Kingdom and Germany. ILUVIEN is in the national phase, pending approval, in eight more EU countries (Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden) following the successful completion of the Mutual Recognition Procedure (MRP) for subsequent marketing authorizations.
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