Alimera Sciences, Inc, a biopharmaceutical company that specialises in the research, development and commercialisation of prescription ophthalmic pharmaceuticals, announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorisation to Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The Iluvien marketing authorisation 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.

The Italian authorisation is the seventh national approval in the EU, preceded by Austria, the United Kingdom, Portugal, France, Germany and Spain. Iluvien is commercially available in the UK. and Germany.

"Iluvien has now been granted marketing authorizations in all seven EU countries in which we initially applied," said Dan Myers, Alimera's president and chief executive officer. "Additionally, we are engaged in a Repeat Use Procedure through Mutual Recognition (MRP) to obtain a positive opinion for approval from another10 EU countries."

"This approval is important news for patients in Italy with DME whose disease has evolved to chronic DME," said Dr. Stanislao Rizzo, chairman of the U.O. Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. "Iluvien is a valuable option for patients who are not sufficiently responding to other treatments."

Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc). Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound. In the FAME Study, a phase 3 clinical study of Iluvien, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure. Iluvien has not been approved for sale in the United States.