Alimera Sciences Inc (ALIM: Quote) Wednesday announced that the National Security Agency of Medicines and Health Products in France has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema, or DME, considered insufficiently responsive to available therapies.
The biopharmaceutical company specializing in the research, development and commercialization of prescription ophthalmic products stated that the French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the U.K.
ILUVIEN is a sustained release intravitreal implant used to treat chronic DME. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide.
"ILUVIEN has now been granted marketing authorizations in four of the seven EU countries in which we have applied. We are continuing to work with regulatory authorities in Germany, Italy and Spain," said Dan Myers, president and chief executive officer, Alimera Sciences. "It's an exciting year for ILUVIEN and a step forward for the many people with chronic diabetic macular edema."
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by RTT Staff Writer
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