UK-based Medicines and Healthcare products Regulatory Agency(MHRA)has granted marketing authorization to pSivida for its Iluvien insert.
The marketing authorization follows the recently announced approval in Austria.
The approvals were based on the completion of the decentralized regulatory procedure(DCP)in the European Union,in which the MHRA delivered a positive outcome for Iluvien along with six concerned members states,specifically Austria,France,Germany,Italy,Spain and Portugal.
Iluvien is an injectable,sustained-release intravitreal insert which releases sub-microgram levels of fluocinolone acetonide(FAc)for up to 36 months for the treatment of chronic diabetic macular edema(DME).
In addition,CMS marketing authorizations are targeted in the coming months and Alimera,a developer of prescription ophthalmic pharmaceutical,expects Iluvien to be available in the EU by the end of 2012.
pSivida president and chief executive officer Paul Ashton said following the approvals,the Iluvien insert will soon be available to patients in the UK and Austria.
"We look forward to ILUVIEN receiving the additional expected EU approvals,"Ashton added.
pSivida is also developing an insert of the same design for the treatment of uveitis which affects the posterior of the eye.
