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pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending ILUVIEN as an option for the treatment of chronic diabetic macular edema (DME) that is insufficiently responsive to available therapies in pseudophakic eyes (those that have already undergone cataract surgery). This recommendation reverses the final draft guidance previously issued by NICE with respect to this subgroup of chronic DME patients.
NICE’s final guidance recommending ILUVIEN to the National Health Service (NHS) is expected to be published in November 2013, which would result in NHS reimbursement in England and Wales under the patient access scheme submitted by Alimera Sciences, pSivida’s licensee.
“We are very pleased with this position by NICE and the expectation that ILUVIEN will be available to treat this significant subgroup of chronic DME patients,” said Dr. Paul Ashton, President and CEO of pSivida. “We are encouraged that Alimera plans to continue to work with NICE in an effort to broaden access to ILUVIEN to include all chronic DME patients who could benefit from the treatment.”
ILUVIEN, a sustained release intravitreal micro-insert, has received marketing authorization in the U.K., Austria, Portugal, Germany, France and Spain, and is pending in Italy. ILUVIEN is currently commercially available in the U.K. and Germany.
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™, including Tethadur™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME) considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Portugal, and Spain and is awaiting authorization in Italy. Alimera resubmitted the New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration and received a PDUFA date of October 17, 2013. pSivida has instituted the first of two planned pivotal Phase III clinical trials for Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye disease, 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, a product candidate on which Pfizer Inc. has an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term, sustained drug delivery to treat posterior uveitis.