EU Approves Allergan's Diabetic Macular Edema Treatment
By Lori Clapper
Allergan, a multi-specialty health care company, announced Tuesday that the European Commission (EU) extended the marketing authorization for Ozurdex, which is the company’s 700 mcg intravitreal implant in applicator made for adults with visual impairment due to diabetic macular edema (DME).
DME is a common complication with diabetes as well as the leading cause of blindness in diabetic patients.
The MEAD (macular edema: Assessment of Implantable Dexamethasone in Diabetes) clinical trial program tested the safety and efficacy of Ozurdex during two, three-year sham-controlled, masked, randomized clinical studies. The research assessed “the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline,” according to a company announcement.
“Following the positive opinion from the European Union’s Committee for Medicinal Products for Human Use just last month, we are particularly pleased that with this license extension for Ozurdex in Europe,” David E.I. Pyott, Allergan’s Chairman of the Board and CEO, said. “In addition to the recent FDA approval in the United States, we are able to offer another important treatment option to help preserve vision for certain patients with DME.”
He added that he was pleased that Allergan’s R&D investments would make new innovative treatment options readily available for physicians and their patients.
Originally developed for the treatment of retinal disease, the Ozurdex implant uses the proprietary biodegradable implant Novadur, which releases medicine over an extended period of time to suppress the inflammation that often causes DME.
DME is considered an important clinical and public health issue. According to the International Diabetes Federation, an estimated two percent of people with diabetes develop DME every year, and the disease is considered to be a growing issue in Europe. In fact, the likelihood of diabetes is expected to increase from 8.5 percent (2013) to 10.3 percent in 2035.