Iluvien gains marketing authorization in Portugal for chronic DME
The National Authority of Medicines and Health Products in Portugal has granted Alimera Sciences authorization to market Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies, according to a press release.
The approval for Iluvien (sustained-release fluocinolone acetonide) in Portugal follows similar marketing authorization in Austria and the United Kingdom.
"Having now received three E.U. national approvals, we are gaining momentum across the continent and are on track to obtain subsequent approvals from additional [concerned member states] in the coming months,” Dan Myers, president and chief executive officer of Alimera, said in the release.
Iluvien is inserted via a 25-gauge needle to allow for a self-sealing wound and provides a therapeutic effect for up to 36 months, the release said.
In November the U.S. Food and Drug Administration declined approval for Iluvien and noted that Alimera’s application did not offer sufficient data supporting the implant’s safety and efficacy for treatment of diabetic macular edema.