According to the company, ILUVIEN (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant used to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FAc).
Norway is the first country to grant national marketing authorisation following the positive outcome in June of the Repeat-Use Procedure application, added the company.
In conjunction, ILUVIEN has been approved for reimbursement in Portugal by INFARMED, the marketing authorisation body of the Portuguese Ministry of Health, following which, the company plans to move forward with commercialisation in Portugal in late 2014.
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