DME implant receives Austrian marketing OK

Atlanta-The Austrian Agency for Health and Food Safety has granted marketing authorization to an intravitreal implant with sustained-release fluocinolone acetonide (Iluvien, Alimera Sciences Inc.) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

The marketing authorization follows the completion of the decentralized regulatory procedure (DCP), in which the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK), serving as the reference member state, delivered a positive outcome for the implant. Six concerned member states (CMS)-Austria, France, Germany, Italy, Spain, and Portugal-participated in the DCP.

The Austrian authorization is the first national approval in the European Union (EU). Additional CMS marketing authorizations are expected in the coming months.

“We are excited to receive this marketing authorization and pleased that patients in Austria [with DME] will have this therapy available to them,” said Dan Myers, president and chief executive officer, Alimera Sciences. “We look forward to receiving the additional expected approvals from the UK and other CMSs as we continue on track with our commercialization plans in the EU.”

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