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