EyePoint Pharmaceuticals Inc (EYPT)

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23.06.2014 | 13:01
www.prnewswire.com/news-releases/alimera-sciences-iluvien-receives-marketing-authorization-in-italy-for-the-treatment-of-chronic-diabetic-macular-edema-264213461.html

PR Newswire
Alimera Sciences' ILUVIEN Receives Marketing Authorization In Italy For The Treatment Of Chronic Diabetic Macular Edema
ATLANTA, June 23, 2014 /PRNewswire/ --Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has 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 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.

The Italian authorization is the seventh national approval in the EU, preceded by Austria, theUnited Kingdom, Portugal, France, Germany and Spain. ILUVIEN is commercially available in the U.K. 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."