Drug delivery company pSivida Corp (NASDAQ:PSDV)(ASX:PVA) today announced that a clinical trial has begun using its MedidurTM delivery technology to treat a form of dry-Age related Macular Degeneration (dry-AMD).
Medidur is a tiny intravitreal insert designed to be administered by an eye care professional, using a proprietary 25-gauge inserter in a minimally invasive, outpatient procedure.
This application of Medidur technology has been licensed to Alimera Sciences and is in pivotal Phase III clinical trials for the treatment of diabetic macular edema (DME), a potentially blinding disease that affects over 1,000,000 people in the US. The Phase III clinical trials were fully enrolled over a year ago with preliminary efficacy and safety results expected in approximately one year. If approved by the FDA, Alimera will market the product under the name IluvienTM.
The new study is an investigator sponsored pilot study designed to assess the saf! ety and efficacy of Iluvien in patients with bilateral geograp! hic atro phy (GA) secondary to dry-AMD and will compare two doses of Iluvien with a sham injection.
“The impetus for this study was the results of experiments conducted in two animal models of retinal degenerations. In both of these models, a miniaturized version of Iluvien demonstrated protective effects on the spontaneous degeneration which occurs in these animals,” said Raymond Iezzi, M.D., of Kresge Eye Institute, Wayne State University School of Medicine. “These results were considered compelling enough to warrant a human study, especially for a condition for which there is no approved treatment,” added Dr. Iezzi.
Dr Paul Ashton, Managing Director of pSivida Corp. said, “We are pleased that another application of our Medidur technology has now entered clinical trials.”
About PSIVIDA LIMITED
pSivida is a drug delivery company committed to the biomedical sector, with a primary focus on ophthalmology and oncology. pSivida has two product! s approved by the Food and Drug Administration (FDA): Retisert(R) to treat uveitis and Vitrasert(R) for treating AIDS-related cytomegalovirus (CMV) retinitis.
pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien(TM), which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.