The European Commission has extended the marketing authorization for Allergan's Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with visual impairment due to diabetic macular edema (DME) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroids therapy. DME is a common complication with diabetes and is the leading cause of sight loss in patients with diabetes.
"Through Allergan's efficient R&D investment, we are able to continually bring forth innovative new treatment options for physicians and their patients while delivering value to our stockholders," said David E.I. Pyott, Allergan's chairman of the Board and chief executive officer. "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, 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."
The safety and efficacy of Ozurdex in the management of patients with DME was assessed in the MEAD (Macular Edema: Assessment of Implantable Dexamethasone in Diabetes) clinical trial programme. MEAD consisted of two multi-centre 3-year sham-controlled, masked, randomized clinical studies assessing the proportion of patients with 15 or more letters improvement in best-corrected visual acuity (BCVA) from baseline.
Developed for the treatment of retinal disease, the Ozurdex implant uses the proprietary innovative Novadur solid polymer delivery system a biodegradable implant that releases medicine over an extended period of time to suppress inflammation, which plays a key role in the development of DME. Ozurdex is already available throughout the European Union as a treatment licensed for macular edema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterised as non-infectious uveitis.
Patients with diabetes are at higher risk of developing some eye complications such as cataracts, diabetic retinopathy (damage to the retina) and diabetic macular edema. In fact, DME is reported to be the major cause of vision loss in patients with diabetes. DME is an important clinical and public health issue; every year, an estimated 2 per cent of people with diabetes develop DME. Indeed, the incidence of DME is likely to rise due to the increased prevalence of diabetes in Europe, which is expected to increase from 8.5 per cent in 2013 to 10.3 per centin 2035.