Industry News — Clinical Updates
Iluvien Receives Marketing Authorization in Ireland for Chronic DME
The Irish Health Products Regulatory Authority (HPRA) has granted marketing authorization to Iluvien (sustained-release fluocinolone acetonide implant; Alimera Sciences, Inc, Atlanta, GA) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The HPRA approval marks the fifth European approval of Iluvien through the Repeat-Use Procedure and the thirteenth approval worldwide.
Iluvien is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom, and the United States, and it is commercially available in the United Kingdom and Germany. It is pending approval in the Czech Republic, Finland, Luxembourg, the Netherlands and Poland.
Updated November 17, 2014