DME therapy obtains European marketing authorization

Apr 30, 2012

Iluvien, an intravitreal implant for the treatment of chronic diabetic macula oedema (DME) developed by Alimera Sciences, has been granted market authorization by the Austrian Agency for Health and Food Safety.

Iluvien, an intravitreal implant for the treatment of chronic diabetic macula oedema (DME) developed by Alimera Sciences, has been granted market authorization by the Austrian Agency for Health and Food Safety.

Iluvien is a sustained release intravitreal implant inserted into the back of the eye. It delivers sub-microgram levels of fluocinolone acetonide (FAc) and can be effective for up to 36 months.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK completed the Decentralized Regulatory Procedure (DCP) and issued a positive outcome to Iluvien. Other countries delivering a positive outcome included Austria, France, Germany, Italy, Spain and Portugal. Additional Concerned Member State (CMS) marketing authorizations are expected later this year.

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

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