Iluvien gains marketing authorization in Spain

The Spanish Agency of Medicines and Medical Devices granted Alimera Sciences authorization to market Iluvien in Spain for the treatment of vision impairment associated with chronic diabetic macular edema that is unresponsive to available therapies, according to a news release.

The decentralized regulatory procedure for Iluvien (sustained-release fluocinolone acetonide) was completed in the European Union in 2012. The authorization in Spain is the sixth national approval in the EU, following Austria, the United Kingdom, Portugal, France and Germany.

“With our European management team now on board, we are looking forward to the initial commercial launch of Iluvien in Germany, expected during the first quarter of 2013,” Dan Myers, president and CEO of Alimera, said in the release. “In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy.”