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news.US-based biopharmaceutical firm Alimera Sciences has received authorization from Danish authorities to sell its drug Iluvien, indicated for the treatment of vision impairment associated with chronic diabetic macular edema (DME), in the country.
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According to the company, Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant, which has a therapeutic effect of up to 36 months.
The drug delivers sustained sub-microgram levels of fluocinolone acetonide (FAc).
The known side-effects of the drug include cataract development and increased ocular pressure.
Denmark is the second country to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application. Iluvien obtained authorization in Norway in July.
The drug is currently approved in Austria, France, Germany, Italy, Norway, Portugal, Spain and the UK, while it is commercially available in the UK and Germany.
Approval is pending in eight more countries including Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden.
Currently, a new drug application for Iluvein is under review by the US Food and Drug Administration.
Alimera president and CEO Dan Myers said: "With Iluvein now approved for marketing in the second Scandinavian country, more patients can gain access across Europe to the only three-year treatment for DME, and the only treatment for the chronic form of the disease.
"We look forward to continuing to expand our geographic footprint through additional national marketing authorizations."
Photo: courtesy of GeeJo