Alimera Sciences'' ILUVIEN Receives Marketing Authorization In The Netherlands For The Treatment Of Chronic Diabetic Macular Edema
Tuesday, December 02, 2014
Alimera Sciences, Inc., a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Dutch Inspectie voor de Gezondheidszorg (IGZ) has granted marketing authorization in the Netherlands to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Approval in the Netherlands marks the sixth European approval through the Repeat-Use application procedure and the 14th approval worldwide, including the recent U.S. approval for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany. ILUVIEN is pending approval in four additional countries in the European Union (EU) included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Luxembourg and Poland.
"We are delighted to add the Netherlands to our roster of countries approved for the commercialization of ILUVIEN," said Dan Myers, Alimera''s president and chief executive officer. "The Netherlands joins a growing list of nations that have agreed to grant access to the only multiyear, single injection treatment option available for DME."
Source : http://investor.alimerasciences.com/
