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DME treatment receives marketing authorization in United Kingdom
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ATLANTA — Iluvien, which recently received marketing authorization in Austria after completing the decentralized regulatory procedure in the European Union, has now received marketing authorization in the United Kingdom, Alimera Sciences reported in a press release.
The authorization covers Iluvien (sustained-release fluocinolone acetonide) for treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies, the release said.
During the decentralized regulatory procedure, the Medicines and Healthcare products Regulatory Agency in the United Kingdom served as the reference member state and delivered a positive outcome along with the six concerned member states, Austria, France, Germany, Italy, Spain and Portugal, according to the release.
Further marketing authorizations are expected in the coming months, the release said. pSivida has licensed Iluvien to Alimera, which expects the drug to be available in the European Union by the end of the year.
Alimera is in discussions with the U.K.’s National Institute for Health and Clinical Excellence to provide guidance to the National Health Service regarding reimbursement for Iluvien, according to the release.