Iluvien approved in Norway and Denmark: pSivida
pSivida (ASX:PVA) licensee Alimera Sciences this week won marketing authorisation in both Norway and Denmark for diabetic macular oedema treatment Iluvien.
The authorisation covers incidents of the eye disease considered insufficiently responsive to available therapies.
The authorisation in Norway marked the first authorisation received under the EU’s Mutual Recognition Procedure (MRP). Alimera used the MRP in July to apply for approval in 10 European countries.
The markets where Iluvien is awaiting approval are Belgium, the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands, Poland and Sweden.
Iluvien has meanwhile been approved for reimbursement in Portugal for the same indication, and Alimera plans to launch the product in the market late this year.
The product is already commercially available in the UK and Germany, and has also been approved in Austria, Portugal, France, Spain and Italy. The US FDA is meanwhile reviewing Alimera’s fourth New Drug Application for the product, and has set a goal date of 26 September for issuing its decision.
Iluvien uses a sustained-release micro-insert designed by pSivida. The company uses the same micro-insert for Medidur, its treatment for posterior uveitis, which is at the trial stage.
pSivida (ASX:PVA) shares were trading unchanged higher at $4.80 as of around 1 pm on Friday
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