pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. While ILUVIEN has received marketing authorization in the U.K., the independent Appraisal Committee concluded that the evidence provided did not show that the benefits ILUVIEN provides to patients justify the proposed price.
pSivida’s licensee, Alimera Sciences, reported that in response to the final draft guidance, it has immediately begun to develop a Patient Access Scheme (PAS) to address NICE’s cost concerns. According to Alimera, the PAS being developed, if accepted, will make ILUVIEN available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that more than 3 million people are currently living with diabetes in the U.K., nearly 200,000 of whom, according to Alimera’s estimates, suffer with vision loss from DME.
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™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal and the U.K. and is awaiting authorization in Italy and Spain. ILUVIEN for DME has not been approved in the US. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-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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