pSivida's Iluvien given marketing authorization in Norway and reimbursement approval in Portugal
Eye disease specialist pSivida (Nasdaq: PSDV) has been granted marketing authorization in Norway for its treatment Iluvien (fluocinolone acetonide intravitreal implant), which aids vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies. It has also been approved for reimbursement in Portugal for the same indication.
The marketing authorization for Norway is the first, following the successful approval in June 2014 of the Mutual Recognition Procedure for Norway and nine other EU states. Authorization is pending in the other nine countries.
It has been approved for reimbursement in Portugal by INFARMED, the marketing authorization body of the Portuguese Ministry of Health. Alimera has reported that it plans to move ahead with commercialization in Portugal in late 2014.
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