Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization 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 Authorization 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 license 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 recognized 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 programs 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 7% of patients with diabetes 1 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 license 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 licensed for macular edema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis. 3