DME implant gets UK OK

Atlanta-The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for 190 µm fluocinolone acetonide intravitreal implant in applicator (Iluvien, Alimera Sciences) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

This marketing authorization follows the completion of the decentralized regulatory procedure in the European Union (EU), in which the MHRA, serving as the “reference member state,” delivered a positive outcome for the fluocinolone acetonide implant along with six “concerned members states”: Austria, France, Germany, Italy, Spain, and Portugal. The UK authorization is the second national approval in the EU, preceded by the approval by Austria. The company expects to receive additional national marketing authorizations in the coming months.

“As the global impact of diabetes expands, there is an increasing need for innovative treatments such as [fluocinolone]. We are pleased to receive marketing authorization from our reference member state and are targeting to make this long-term therapy available to the many DME patients there by the end of this year,” said Dan Myers, president and chief executive officer of Alimera Sciences.

The sustained-release intravitreal implant delivers sub-microgram levels of fluocinolone acetonide for up to 36 months.

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