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Alimera Sciences has announced a positive outcome of the Decentralized Procedure (DCP) for its intravitreal implant, ILUVIEN, in Europe...
Alimera Sciences has announced a positive outcome of the Decentralized Procedure (DCP) for its intravitreal implant, ILUVIEN, in Europe following the issuance of the Final Assessment report, from several bodies, stating it is approvable.
The fluocinolone acetonide intravitreal implant will be the first sustained release treatment for chronic diabetic macular oedema (DME) available in the European Union. Countries granting the licence of ILUVIEN for the treatment of chronic DME in cases that are not responding to alternative therapies include Austria, France, Germany, Italy, Portugal and Spain.
Dan Myers, president and chief executive officer of Alimera, said, "Achieving a favourable conclusion for ILUVIEN in Europe is a significant milestone and very encouraging for the many patients with this challenging chronic disease. We will continue to work closely with the UK and the Concerned Member States to ensure that ILUVIEN is made available to patients as soon as possible."
The implant works through delivery of sustained sub-microgram levels of fluocinolone acetonide, which is facilitated by the positioning of the implant at the back of the eye, allowing it to synchronize with the natural fluid dynamics. It has been proven in a 36-month clinical trial to improve the best-corrected visual acuity by 15 letters or more of DME patients when compared with a sham group.
According to senior vice president of sales and marketing at Alimera Sciences, David Holland, "An effective, truly long-term treatment option could have a very positive impact on the quality of life for patients with this chronic debilitating disease."