pSivida new Clinical Trial for Drug Delivery Device in AMD
News Dec 12, 2008
Drug delivery company pSivida Corp has announced that a clinical trial has begun using its Medidur™ 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 Iluvien™.
The new study is an investigator sponsored pilot study designed to assess the safety and efficacy of Iluvien in patients with bilateral geographic atrophy (GA) secondary to dry-AMD and will compare two doses of Iluvien with a sham injection.