pSivida Corp. (PSDV) Wednesday announced the National Security Agency of medicines and health products in France 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.
Iluvien is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic DME. pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye.
This marketing authorization follows the completion of the decentralized regulatory procedure in the European Union, in which the medicines and healthcare products regulatory agency in the United Kingdom, serving as the reference member state, delivered a positive outcome for Iluvien along with six concerned members states, specifically Austria, France, Germany, Italy, Portugal and Spain. The French authorization is the fourth national approval in the EU, preceded by Austria, Portugal and the UK.
The International Diabetes Federation estimates that more than 4.3 million people are currently living with diabetes in France, and according to Alimera's estimates, more than 220 thousand people suffer from vision loss associated with DME.
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