Allergan, Inc announced that the European Union's Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorisation for Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss 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-corticosteroid therapy. The CHMP is the scientific committee of the European Medicines Agency (EMA) that recommends medicines for Marketing Authorisation across the 28 member states of the European Union. The final decision from the European Commission is expected within a few months.

"With a commitment to the development of innovative treatment options that address unmet patient needs, we are pleased with the CHMP's recommendation to expand the licence for Ozurdex, an important tool in the armamentarium of the European retinal specialist, as evidenced by the fact that Ozurdex sales are currently more than twice those of the United States," said David E.I. Pyott, Allergan's chairman of the Board and chief executive officer. "Allergan is widely recognised for having one of the most productive R&D pipelines in the industry and secured a record 180-plus approvals for products and indications around the world last year. Our ability to advance R&D programmes allows us to continually bring forth new treatment options for physicians and their patients while delivering value to our stockholders."

DME is a condition that affects approximately 7per cent of patients with diabetes1 and is the leading cause of sight loss in patients with diabetes.2 The Ozurdex implant uses the proprietary and 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 a leading treatment for macular edema in patients with retinal vein occlusion and uveitis in Europe, and is approved for multiple indications in the United States including most recently for use in certain patients with diabetic macular edema," said Scott M. Whitcup, M.D., Allergan's executive vice president, research and development, chief scientific officer. "DME is a complicated disease to treat, and the additional licence for Ozurdex in the EU would offer another important treatment option to help preserve vision for patients."

Ozurdex (dexamethasone 700 mcg intravitreal implant in applicator) is already available throughout the European Union as a treatment licenced 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 patients with DME, swelling and fluids leaking into the macular (the part of the eye where focusing occurs) can lead to blurred vision, vision loss and eventual blindness. In fact, DME is reported to be the major cause of vision loss in patients with diabetes.2 DME is an important clinical and public health issue; every year, an estimated 2per cent of people with diabetes develop DME.6 Indeed, the incidence of DME is expected to rise due to the increased prevalence of diabetes in Europe, from 8.5per cent in 2013 to 10.3per cent in 2035.