Diabetes News
Retisert(TM) Slows Progression of Diabetic Retinopathy in Diabetic Macular Edema Trials
April 3rd - Global bio-nanotech company pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced additional two year trial results of Bausch & Lomb's two randomized trials to evaluate the safety and efficacy of the Retisert(TM) implant in releasing fluocinolone acetonide in the management of Diabetic Macular Edema (DME). Bausch & Lomb, exclusive licensee of Retisert(TM) from pSivida conducted the studies in hospitals in the United States involving 277 patients. The trial results were presented at the prestigious 6th International Symposium on Ocular Pharmacology and Therapeutics in Berlin that commenced on 30 March 2006 http://www.kenes.com/isopt/index.asp.
The two year trial results demonstrated that 30% of eyes receiving standard of care (repeat laser treatment) had a worsening of their Diabetic Retinopathy compared with only 10% of eyes receiving a Retisert(TM) implant. This was statistically significant. Retisert(TM) also reduced retinal thickening involving the fovea (the center most part of the macula responsible for sharp, central vision) and led to a statistically significant three line improvement in vision.
Diabetic Retinopathy (DR) is the leading cause of vision loss of people in the United States under the age of 65 with an estimated 1,000,000 treatable cases. DR occurs when diabetes damages the tiny blood vessels inside the retina, the light-sensitive tissue at the back of the eye. DR usually affects both eyes. Currently the only FDA approved treatment is laser therapy in which holes are burned into the macula with a laser. This treatment is often ineffective or generally provides only temporary benefit. DME is a common complication of DR. There are no approved drug therapies for the treatment of either DME or DR.
"We believe the finding that sustained release fluocinolone acetonide can slow or reduce the progression of Diabetic Retinopathy is important and may have significant implications for Retisert(TM) and Medidur(TM)," said Mr Gavin Rezos, CEO of pSivida Limited.
pSivida receives royalties on Retisert(TM) sales. Retisert(TM) is presently priced at US$18,250 and is approved as a 30 month treatment for chronic non-infectious posterior segment uveitis, a sight threatening condition that affects an estimated 175,000 people in the United States and an estimated 800,000 people worldwide. Covered in the United States by Medicare and Medicaid, Retisert(TM) is co-marketed in the United States by Bausch & Lomb and Novartis.
Three year results of the Retisert(TM) in DME trial will be presented at ARVO conference in May 2006 www.arvo.org.
