The Federal Ministry of Health of Germany has granted marketing authorization to pSivida for injectable, sustained-release intravitreal insert, Iluvien, designed as a treatment for vision impairment associated with chronic diabetic macular edema (DME).
ILUVIEN releases sub-microgram levels of fluocinolone acetonide for up to 36 months for the treatment of chronic DME.
This marketing authorization follows the completion of the decentralized regulatory procedure in the European Union (EU).
In the decentralized regulatory procedure, UK-based Medicines and Healthcare products Regulatory Agency (MHRA), served as the Reference Member State (RMS) and delivered a positive outcome for Iluvien along with six concerned members states including Austria, France, Germany, Italy, Portugal and Spain.
pSivida president and chief executive officer Paul Ashton said the company’s product now has marketing authorization in five of the seven targeted EU countries.
"We look forward to ILUVIEN’s commercial launch in these countries and to it receiving approval in the two remaining CMS countries, Italy and Spain, in the coming months," Ashton added.