(By Balaseshan) pSivida Corp. (NASDAQ:PSDV), which develops drug delivery products, said the Iluvien to treat chronic diabetic macular edema has received marketing authorization in the United Kingdom.
Additional CMS marketing authorizations are expected in the coming months and Alimera Sciences Inc. (NASDAQ:ALIM) has reported it continues to expect Iluvien to be available in the European Union by the end of 2012.
The Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) has granted marketing authorization for Iluvien for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Iluvien is an injectable, sustained-release intravitreal insert that releases sub-microgram levels of fluocinolone acetonide (FAc) 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 recently announced approval in Austria. These approvals were preceded by completion of the Decentralized Regulatory Procedure (DCP) in the European Union (EU), in which the MHRA, serving as the Reference Member State (RMS), delivered a positive outcome for Iluvien along with six Concerned Members States, specifically Austria, France, Germany, Italy, Spain and Portugal.
The International Diabetes Federation expects that more than 3 million people are currently living with diabetes in the U.K., and Alimera estimates, nearly 200,000 suffer with vision loss from DME.
Alimera has reported it is currently in advanced discussions with the U.K.'s National Institute for Health and Clinical Excellence (NICE) to provide guidance to the National Health Service on the reimbursement of Iluvien.
PSDV is trading up 5.66% at $2.24 on Monday. The stock has been trading between $1.02 and $5.23 for the past 52 weeks.