pSivida Corp. Announces United Kingdom
Grants ILUVIEN® Marketing Authorization for
the Treatment of Chronic Diabetic Macular Edema
WATERTOWN, Mass.--(BUSINESS WIRE)--
pSivida Corp. (NASDAQ: PSDV - News) (ASX: PVA.AX - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced 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.
Additional CMS marketing authorizations are expected in the coming months and Alimera has reported it continues to expect ILUVIEN to be available in the EU by the end of 2012.
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.
“We are extremely pleased ILUVIEN has received this marketing authorization and will soon be available to patients in the UK and Austria,” said Dr. Paul Ashton, president and chief executive officer of pSivida. “We look forward to ILUVIEN receiving the additional expected EU approvals.”
The International Diabetes Federation estimates 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.
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.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. ILUVIEN® for the treatment of Diabetic Macular Edema (DME), which is licensed to Alimera Sciences, Inc., is pSivida’s most advanced product candidate, and based on a consensus arrived upon by the RMS and the CMS, the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) issued its Final Assessment Report that ILUVIEN for chronic DME is approvable. The MHRA and the Austrian Agency for Health and Food Safety has granted marketing authorization to ILUVIEN for chronic DME considered insufficiently responsive to available therapies and the additional CMS marketing authorizations are expected in 2012. An investigator-sponsored Investigational New Drug application opened for an injectable insert to treat posterior uveitis of the same design as ILUVIEN for DME, and an investigator-sponsored trial is ongoing for an injectable, bioerodible insert to treat glaucoma and ocular hypertension. pSivida’s two FDA-approved products, Retisert® and Vitrasert®, are implants that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina.
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