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news.US-based biopharmaceutical firm Alimera Sciences has received marketing authorization from the Norwegian Medicines Evaluation Board for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
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Apart from Norway, ILUVIEN is now approved for marketing in Austria, France, Germany, Italy, Portugal, Spain and the UK, and is commercially available in the UK and Germany.
The company said that ILUVIEN is pending approval in an additional nine countries included in the Repeat-Use Procedure and the countries are Belgium, the Czech Republic, Denmark, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden.
Currently, ILUVIEN is under review by the US Food and Drug Administration.
In addition, ILUVIEN has been approved for reimbursement in Portugal by the marketing authorization body of the Portuguese Ministry of Health ‘INFARMED’.
The company intends to move forward with commercialization of ILUVIEN in Portugal in late 2014.
Alimera president and chief executive officer Dan Myers said with marketing approval in Norway and reimbursement approval in Portugal, ILUVIEN is gaining traction across Europe.
"We are committed to providing widespread patient access to this effective, long-term treatment," Myers said.
Image: Norwegian Medicines Evaluation Board grants marketing authorization to ILUVIEN to treat vision impairment associated with chronic diabetic macular edema. Photo: courtesy of GeeJo