pSivida Corp. (NASDAQ: PSDV - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has published final guidance indicating that ILUVIEN ® is not cost effective for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. This final guidance is consistent with the final draft guidance issued on November 29, 2012.
pSivida’s licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported that it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN for DME that is intended to allow treatment decisions to be based on patient need, rather than cost. Alimera further reported that the PAS is currently under review by the Patient Access Schemes Liaison Unit (PASLU) at NICE and that, if approved by the Department of Health, the PAS will be available to the Appraisal Committee for review and consideration. Alimera stated its belief that the PAS could be considered under NICE’s rapid review facility should the PAS be accepted.
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, Spain and the U.K. and is awaiting authorization in Italy. ILUVIEN for DME has not been approved in the U.S. 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.