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, a potentially blinding disease. 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 secondary to dry-age related macular degeneration (AMD) and will compare two doses of Iluvien with a sham injection.
Raymond Iezzi, of Kresge Eye Institute, Wayne State University School of Medicine, said: 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. These results were considered compelling enough to warrant a human study, especially for a condition for which there is no approved treatment.