Portugal OKs fluocinolone acetonide implant

Atlanta-Portugal’s National Authority of Medicines and Health Products has granted marketing authorization to Alimera Science’s proprietary preparation of 190 µg fluocinolone acetonide intravitreal implant in applicator (Iluvien) for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies, according to the company.

This marketing authorization follows the completion of the decentralized regulatory procedure in the European Union (EU), 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 fluocinolone implant along with six concerned member states (CMSs), specifically Austria, France, Germany, Italy, Portugal, and Spain. The Portuguese authorization is the third national approval in the EU, preceded by Austria and the UK.

“[The] authorization in Portugal is significant news for the many people there with chronic DME who[se conditions] haven't responded well to available therapies,” said Dan Myers, president and chief executive officer, Alimera Sciences. “Having now received three EU national approvals, we are gaining momentum across the continent and are on track to obtain subsequent approvals from additional CMSs in the coming months.”

The intravitreal implant delivers sub-microgram levels of fluocinolone for up to 36 months for the treatment of chronic DME.

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