Data Safety Monitoring Board Supports Continuation Of Phase III Clinical Trial Of Medidur(TM) FA For The Treatment Of Diabetic Macular Edema

Main Category: Eye Health / Blindness
Also Included In: Diabetes;  Clinical Trials / Drug Trials
Article Date: 26 Mar 2008 - 15:00 PDT

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pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI) announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study can continue under the current protocol, without change. The trial is studying the use of Medidur FA for the treatment of diabetic macular edema (DME).

FAME is two, duplicate, double-masked, randomized, multi-center studies that are following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up. Enrollment for the FAME study was completed in October 2007.

"pSivida is very pleased that the DSMB has supported the continuation of this pivotal trial and we remain on track to file an NDA for this product in early 2010," said pSivida Managing Director, Dr. Paul Ashton. "Following the recent amendment to the licensing agreement with our development partner, we continue to have a significant financial interest in Medidur FA and other products developed under this agreement without an obligation to fund the development of the products. Earlier this month, pSivida announced that it has amended its licensing agreement with development partner, Alimera Sciences to reduce its share in the future profits of Medidur FA from 50% to 20% in return for consideration of up to approximately US$78m from Alimera."

Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.

Currently, 7.5 percent of the US population has diabetes. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. In the United States, as many as 200,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved drug treatments for DME.

A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing studies. The FAME DSMB, a group comprised of four ophthalmologists and a biostatistician, met to review the Medidur FA Phase III clinical trial data. The DSMB's charter stipulates that a formal review occur every six months in addition to their ongoing review of the trial.

Notes

pSivida is a global drug delivery company committed to the biomedical sector and the development of drug delivery products. Retisert® is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch & Lomb owns the trademarks Vitrasert® and Retisert®. pSivida has licensed the technologies underlying both of these products to Bausch & Lomb. The technology underlying Medidur™ for diabetic macular edema is licensed to Alimera Sciences and is in Phase III clinical trials. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. for other ophthalmic applications of the Medidur™ technology (excluding FA).

pSivida owns the rights to develop and commercialize a modified form of silicon (porosified or nano-structured silicon) known as BioSilicon™, which has applications in drug delivery, wound healing, orthopedics, and tissue engineering. The most advanced BioSilicon™ product, BrachySil™ delivers a therapeutic, P32 directly to solid tumors and is presently in Phase II clinical trials for the treatment of pancreatic cancer.

pSivida's intellectual property portfolio consists of 64 patent families, 113 granted patents, including patents accepted for issuance, and over 280 patent applications. pSivida conducts its operations from Boston in the United States, Malvern in the United Kingdom and Perth in Australia.

pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange (PSD) and on the Frankfurt Stock Exchange on the XETRA system (PSI). pSivida is a founding member of the NASDAQ Health Care Index and the Merrill Lynch Nanotechnology Index.

pSivida Limited