JAN 18, 2013
Alimera Sciences, Inc. yesterday announced approval from the Spanish Agency of Drugs and Medical Devices to market Iluvien, a fluocinolone acetonide implant for diabetic macular edema (DME). The Spanish authorization is the sixth of seven expected approvals in the European Union, preceded by Austria, the United Kingdom, Portugal, France and, most recently, 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," said Alimera president and CEO Dan Myers. "In addition, we continue to work closely with the Italian regulatory authorities to secure marketing authorization in Italy."
In October Alimera announced the closing of a $40 million round of Series A financing that the company plans to use to market Iluvien for the treatment of DME in Europe.
In November the U.S. Food and Drug Administration refused to approve the drug and asked for new trials, citing insufficient safety and efficacy data. The FDA also ruled that the drug's risks, including cataracts and increased IOP, were not offset by its benefits. Alimera plans to resubmit the application.