While U.S. marketing approval appears to be out of reach for Alimera and pSivida for Iluvien for the sustained release treatment of diabetic macular edema, the first of six expected approvals for Europe has been obtained. The companies announced that the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) had granted marketing authorization to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
The Austrian authorization is the first national approval in the EU. Additional Concerned Members States (CMS) marketing authorizations are expected (Read more...)