Fluocinolone acetonide implant gets German marketing approval

Atlanta-An intravitreal implant that delivers sub-microgram levels of fluocinolone acetonide for up to 36 months (Iluvien, Alimera Sciences Inc.) has been granted marketing authorization by the Federal Ministry of Health of Germany (Bundesministerium fur Gesundheit, BfArM) for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.

This marketing authorization follows the completion of the decentralized regulatory procedure, in which the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, serving as the reference member state, delivered a positive outcome for the implant along with six concerned members states: Austria, France, Germany, Italy, Spain, and Portugal. The German authorization is the fifth national approval in the European Union, preceded by Austria, Portugal, the United Kingdom, and France.

“We are very pleased to receive German marketing authorization for [the fluocinolone acetonide implant], our fifth of seven expected approvals in the European Union,” said Dan Myers, president and chief executive officer, Alimera Sciences. “Assuming the closing of our recently announced financing, we anticipate that we will launch [the implant] in Germany during the first quarter of 2013.”

For more articles in this issue of Ophthalmology Times eReport, click here.