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news.Alimera Sciences has received marketing authorization from the Swedish Medical Products Agency for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME).
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Apart from Sweden, ILUVIEN is currently approved for marketing in Austria, Denmark, France, Germany, Italy, Norway, Portugal, Spain and the UK, and is commercially available in the UK and Germany.
According to the company, ILUVIEN is pending approval in an additional seven countries from in its Repeat-Use Procedure and the countries include Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.
At present, a new drug application (NDA) for ILUVIEN is under review by the US Food and Drug Administration (FDA).
Alimera president and chief executive officer Dan Myers said Sweden is now the third country to grant marketing authorization for ILUVIEN from the company’s Repeat-Use Procedure application.
"As DME is often a disease that persists, we are excited by the prospect of enabling retinal physicians in additional countries to provide their patients with the only three-year treatment for DME," Myers said.
"We look forward to continuing to expand our geographic presence in Europe through additional national marketing authorizations."