DME treatment to be marketed in Europe

Atlanta-An intravitreal insert with sustained-release fluocinolone acetonide (Iluvien, Alimera Sciences) is approvable for use as a treatment for diabetic macular edema (DME) in Europe, according to the outcome of the decentralized procedure (DCP) for multinational marketing there.

Applicants who wish to market a product in various European Union (EU) countries and have not received authorization from any EU country may obtain marketing authorization through the DCP. One country acts as a “reference member state” (RMS) and assesses the application, then works with the “concerned member states” (CMSs) in which the applicant seeks to market the product. In addition to the RMS and CMSs, the DCP also includes the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom.

The regulatory process now will enter the national phase, in which the RMS and each CMS grants a national license. In this case, the CMSs include Austria, France, Germany, Italy, Portugal, and Spain.

Sustained-release fluocinolone acetonide will be indicated for the treatment of vision impairment associated with chronic DME insufficiently responsive to available therapies. The intravitreal implant treats chronic DME by releasing sub-microgram levels of the drug for up to 36 months.

“Achieving a favorable conclusion for [sustained-release fluocinolone acetonide] in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease,” said Dan Myers, president and chief executive officer of Alimera Sciences. “We will continue to work closely with the UK and the CMS to ensure that [the drug] is made available to patients as soon as possible.”

In November, the FDA told Alimera that two clinical trials would need to be conducted to demonstrate the safety and effectiveness of the insert before it could decide whether to approve a new drug application for its use in the United States.

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