IRVINE, CA, USA I September 2, 2014 I Allergan, Inc. (AGN) announced today that the European Commission has extended the Marketing Authorization for 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.1 DME is a common complication with diabetes and is the leading cause of sight loss in patients with diabetes.2,3,4
“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 program.1,5 MEAD consisted of two multi-center 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 characterized as non-infectious uveitis.1
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.6,7 In fact, DME is reported to be the major cause of vision loss in patients with diabetes.4 DME is an important clinical and public health issue; every year, an estimated 2% of people with diabetes develop DME.8 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% in 2013 to 10.3% in 2035.9
About Allergan
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 11,700 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.
SOURCE: Allergan
Post Views: 132
IRVINE, CA, USA I September 2, 2014 I Allergan, Inc. (AGN) announced today that the European Commission has extended the Marketing Authorization for 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.1 DME is a common complication with diabetes and is the leading cause of sight loss in patients with diabetes.2,3,4
“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 program.1,5 MEAD consisted of two multi-center 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 characterized as non-infectious uveitis.1
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.6,7 In fact, DME is reported to be the major cause of vision loss in patients with diabetes.4 DME is an important clinical and public health issue; every year, an estimated 2% of people with diabetes develop DME.8 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% in 2013 to 10.3% in 2035.9
About Allergan
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 11,700 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.
SOURCE: Allergan
Post Views: 132
