-The  National Security Agency of Medicines and Health Products of France has granted  marketing authorization for a 190-µg fluocinolone acetonide intravitreal  implant in applicator (Iluvien, Alimera Sciences) for the treatment of vision  impairment associated with chronic diabetic macular edema (DME) considered  insufficiently responsive to available therapies.

The French authorization is the fourth national approval in the  European Union, having been preceded by approvals in Austria, Portugal,  and the UK. Dan Myers, president and chief executive officer of the company,  says that Alimera continues to work with regulatory authorities in Germany,  Italy, and Spain to gain marketing authorization in those countries.

“It's an exciting year for [the implant] and a step forward for the  many people with chronic DME,” he added.

The sustained-release intravitreal implant delivers sub-microgram  levels of fluocinolone acetonide for up to 36 months for the treatment of  chronic DME. Clinical trial data showed that 38% of patients who had chronic  DME at month 30 experienced an improvement from baseline in their  best-corrected visual acuity on the Early Treatment of Diabetic Retinopathy  Study eye chart of 15 letters or more after receiving the drug. At the  completion of the 36-month study, the same result had been achieved in 34% of  the patients. This effect was highly statistically significant as compared with  the sham control group, which received laser and other intravitreally  administered therapies.

Marketing authorization has been granted for a 190-µg fluocinolone acetonide intravitreal implant in applicator (Iluvien, Alimera Sciences) for chronic diabetic macular edema (DME).