IRVINE, Calif. -- (BUSINESS WIRE) -- Allergan, Inc. (NYSE: AGN) 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 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 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
About Diabetic Macular Edema (DME)
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.4,5 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 2% 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 8.5% in 2013 to 10.3% in 2035.7
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life's potential. Today, we have approximately 11,600 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and customers who rely on our products and the employees and communities in which we live and work.
This press release contains "forward-looking statements", including the statements by Mr. Pyott and Dr. Whitcup, as well as other statements regarding research and development outcomes, efficacy, adverse reactions, potential for the European Commission granting final Marketing Authorization, market and product potential, product availability and other statements regarding OZURDEX®. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; challenges related to achieving regulatory approval on a timely and cost-efficient manner, or if at all; technological advances and patents attained by competitors; challenges inherent in the research and development process; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan is available at www.allergan.com.
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1 Yau JWY et al. Global Prevalence and Major Risk Factors of
Diabetic Retinopathy Diabetes Care 2012;35: 556-564
2 Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes 2011; 2(6): 98-104
3 OZURDEX® Summary of Product Characteristics (www.medicines.org.uk)
4 Obrosova IG et al. Diabetic cataracts: mechanisms and management Diabetes Metab Res Rev 2010;26: 172-180
5 Ciulla TA et al. Diabetic Retinopathy and Diabetic Macular Edema Diabetes Care 2003;26: 2653-2664
6 Klein R et al. The Wisconsin epidemiologic study of diabetic retinopathy XV. The long-term incidence of macular edema. Ophthalmology 1995;102:7–16.
7 International Diabetes Federation (IDF). IDF Diabetes Atlas - 2013;Sixth Edition: 1-160