Italy Oks Iluvien for chronic DME

Alimera Sciences announced it has received marketing authorization from the Italian Medicines Agency for Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema, according to a company press release.

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

Iluvien is a designated C class product in Italy, meaning that is currently available only to private-paying patients. If Iluvien reaches H class designation, patient access to Iluvien will be expanded, the release said.