Alimera's Iluvien is granted marketing authorization for DME in Italy

The Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization for Iluvien (fluocinolone acetonide intravitreal implant) from US ophthalmic pharma specialist Alimera Sciences (Nasdaq: ALIM).

Iluvien is intended for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. The Iluvien marketing authorization notice was published on June 18 in the Gazzetta Ufficiale della Repubblica Italiana, the official journal of record of the Italian government. Designated a C Class product in Italy, Iluvien will be available initially to private paying patients. Alimera is pursuing H Class designation for Iluvien with the Italian regulatory authorities, which, if granted, would expand patient access to the product.

Dan Myers, Alimera's president and chief executive, said: “Iluvien has now been granted marketing authorizations in all seven EU countries in which we initially applied. Additionally, we are engaged in a Repeat Use Procedure through Mutual Recognition (MRP) to obtain a positive opinion for approval from another 10 EU countries.”