Ozurdex(R) (dexamethasone 0.7mg) now available for millions of patients in China with macular edema secondary to retinal vein occlusion

-- An estimated 7.4 million people in China are living with this sight-threatening conditioni,ii,iii --

DUBLIN, March 22, 2018 /PRNewswire/ -- Today, Allergan plc (NYSE:AGN) announces the launch of Ozurdex® (dexamethasone intravitreal implant 0.7 mg) in China for the treatment of adult patients with macular edema secondary to retinal vein occlusion (RVO). RVO is the second most common type of retinal vascular disorder after diabetic retinal diseaseiv and it is estimated that 7.4 million people in China are living with the condition.i,ii,iii

RVO is caused by blockages in the central retinal vein (CRVO) or in the surrounding branch retinal veins (BRVO) which leads to disrupted blood flow, haemorraghing and eventually macular edema.v If left untreated, RVO can result in sudden and painless loss of vision.vi Symptoms of the disease include blurry vision and floaters (dark spots and lines in vision).vii, viii

Ozurdex® is the first approved intravitreal injection for RVO in China and is licensed for the treatment of macular edema following BRVO and CRVO. Allergan has accelerated access to this treatment in 27 hospitals across China, making it available as a first-line treatment for this potentially sight-threatening condition. Ozurdex® was put on the priority approval list by the Chinese Food and Drug Administration (CFDA) and was granted an Imported Drugs Licence (IDL) in October 2017.

Dr. Dai Hong, Director of Ophthalmology at Beijing Hospital comments, "RVO is a devastating condition that affects millions of patients in China. It can lead to macular edema, the thickening of the macular region in the eye, and if left untreated results in poor vision. Macular edema is the leading cause of visual impairment in RVO. Being able to offer these patients a proven treatment option allows ophthalmologists to consider a more tailored management approach, helping to reduce the treatment burden for patients and alleviate pressure on local eye care services."

Ozurdex® is a biodegradable implant containing the anti-inflammatory corticosteroid, dexamethasone. It is implanted in the back of the eye, via a single use applicator, and the implant slowly releases dexamethasone directly to the retina over a period of several months.ix Inflammation plays a role in the development of RVO and is a critical component in macular edema.x This treatment works by suppressing inflammatory mediators and delivers sustained visual gains.xi

"Providing millions of RVO patients access to Ozurdex® is a significant step towards preventing blindness and meeting a critical unmet need in China," comments Marc Princen, Allergan International President. "As the global prevalence of eye diseases grows, Allergan remains committed to reducing this burden and delivering innovative treatments to people most in need around the world."

About retinal vein occlusion (RVO)?

Retinal vein occlusion is the second most common cause of reduced vision due to a retinal vascular disorder; the most common cause is diabetic retinopathy.i It is defined as obstruction of a retinal vein, which causes haemorrhage in the retina. This process eventually leads to macular edema, i.e. thickening of the macular region. Left untreated, macular edema can result in decreased visual acuity.iv 

Retinal vein occlusion occurs when the circulation of the retinal vein becomes blocked by an adjacent blood vessel or thrombosis. It can be classified according to the location of the occlusion. BRVO occurs in a branch retinal vein and CRVO occurs in the central retinal vein and involves all four quadrants of the retina. BRVO and CRVO have distinct underlying causes, prognoses and outcomes, and commonly require different management strategies.iv

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.  

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 

i Laouri M, et al. The burden of disease of retinal vein occlusion: review of the literature. Eye. 2011;25(8):981-988.
ii Liu W. et al. Vein Occlusion in Chinese Subjects. Ophthalmology 2007; 114; 1795-1796.
iii 2016 China Age Structure data http://www.indexmundi.com/china/age_structure.html Last Accessed March 2018.
ivRoyal College of Ophthalmologists. Retinal vein occlusion (RVO) guidelines. London: Royal College of Ophthalmologists, 2015.
v Moorfields Eye Hospital, Retinal Vein Occlusion https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion Last accessed March 2018.
vi Jia L. et al. New Developments in the Classification, Pathogenesis, Risk Factors, Natural History, and Treatment of Branch Retinal Vein Occlusion. Journal of Ophthalmology 2017, Article ID 4936924, 18 pages https://doi.org/10.1155/2017/4936924 Last Accessed March 2018.
vii American Academy of Ophthalmology, Central Retinal Vein Occlusion (CRVO) symptoms, 2017. https://www.aao.org/eye-health/diseases/central-retinal-vein-occlusion-symptoms Last accessed March 2018.
viii American Academy of Ophthalmology, Branch Retinal Vein Occlusion (BRVO) symptoms, 2017. https://www.aao.org/eye-health/diseases/branch-retinal-vein-occlusion-symptoms Last accessed March 2018.
ix Allergan Ltd. Ozurdex Summary of Product Characteristics http://www.medicines.org.uk/emc/product/5654 Last Accessed March 2018.
x Deobhakta A, Chang LK. Inflammation in Retinal Vein Occlusion. International Journal of Inflammation. 2013; 2013:438412.
xi Aodishi® (OZURDEX®) (Package Insert) Shanghai, China, Allergan PLC, Dublin Ireland 2017




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