The National Security Agency of Medicines and Health Products in France has granted marketing authorization to pSivida's ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME).
The injectable, sustained-release intravitreal insert releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME. The company is developing an insert of the similar design to treat uveitis affecting the posterior of the eye.
pSivida president and chief executive officer Paul Ashton said the company now has marketing authorization in four of the seven targeted EU countries.
"We look forward to ILUVIEN receiving approval in the three remaining CMS countries, Germany, Italy and Spain, in the coming months," Ashton added.
The authorization followed the completion of the Decentralized Regulatory Procedure in the EU, 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.
