Allergan Receives Approval for Ozurdex® (Dexamethasone Intravitreal Implant 0.7 mg) in China for the Treatment of Retinal Vein Occlusion (RVO)

DUBLIN, Oct. 30, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that it has received an Imported Drugs License (IDL) from the Chinese Food and Drug Administration (CFDA) to market Ozurdex® (dexamethasone intravitreal implant 0.7 mg) for the treatment of adult patients with macular edema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO). 

Ozurdex is the first approved intravitreal injection for RVO in China. Retinal vein occlusion (RVO) is the second most common type of retinal vascular disorder after diabetic retinal disease and one of the most common causes of sudden, painless, unilateral loss of vision.ⁱ It is estimated that there are around 7.4 million patients in China with RVO who require treatment. ^ii,iii,iv

"Ozurdex addresses a clear unmet need in Chinese patients with RVO, a potentially blinding disease if left untreated," explained David Nicholson, Chief Research and Development Officer at Allergan. "Inflammation is a critical component in RVO leading to macular edema and potential vision loss. Ozurdex suppresses mediators of inflammation and delivers rapid and sustained visual gains.^v,vi As the prevalence of eye diseases and blindness grows in Asia^vii, we are committed to improving access to innovative medicines and individualised treatments like Ozurdex that provide rapid improvements in visual acuityv and importantly, reduce the burden of injection for patients."

Ozurdex is a biodegradable implant containing dexamethasone, an anti-inflammatory corticosteroid, in a single use applicator. Following an intravitreal injection into the back of the eye, the implant slowly releases the dexamethasone directly to the retina over a period of several months.^viii

"As a result of its clinical performance, Ozurdex was put on the priority approval list by the Chinese Food and Drug Administration (CFDA). The approval of Ozurdex underscores our commitment to bring more innovative eye care solutions to tackle unmet medical needs in China. Coming next, Allergan China will be accelerating access to Ozurdex for Chinese hospitals – and more importantly to Chinese patients," said Shirley Zhao, Allergan China President.

The clinical efficacy and safety of Ozurdex has been assessed in three phase III randomised, double-masked, sham-controlled studies. Based on the pooled analysis of the two global pivotal studies RVO1 and RVO2 as well as the China registration study RVO3 results, treatment with Ozurdex showed statistically significant improvements in visual gains compared with sham treatment. The most commonly-reported adverse events following treatment with Ozurdex are those frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract formation and conjunctival or vitreal haemorrhage respectively).^vi 

Commenting on the announcement, Marc Princen, Allergan International President said, "We are delighted to receive this approval, which means we can now provide RVO patients in China with an effective treatment option. China is a very important market for Allergan; it's the second largest pharmaceutical market in the world after the US and furthermore has the largest number of people with visual impairment and blindness globally. We are committed to bringing innovative treatments to these patients and help improve their quality of life."

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.^ix,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.^x Left untreated, macular edema can result in decreased visual acuity.^xi

Retinal vein occlusion occurs when the circulation of the retinal vein becomes blocked by an adjacent blood vessel or thrombosis.^xi 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.^xii BRVO and CRVO have distinct underlying causes, prognoses and outcomes, and commonly require different management strategies. ^xii

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 commercialising 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 with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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; 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, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

References

[i] 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 October 2017. 
[ii] Laouri M. et al. The burden of disease of retinal vein occlusion: review of the literature. Eye 2011; 25: 981-988. 
[iii] Liu W. et al. Vein Occlusion in Chinese Subjects. Ophthalmology 2007; 114; 1795-1796. 
[iv] 2016 China Age Structure data http://www.indexmundi.com/china/age_structure.html Last Accessed October 2017. 
[v] Haller J.A. et al. Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion: 12 month study results. Ophthalmology 2011;118:2453–60.  
[vi] Aodishi^®(OZURDEX^®) (Package Insert) Shanghai, China, Allergan PLC, Dublin Ireland 2017 
[vii] World Health Organization. Blindness as a public health problem in China. Fact Sheet No 230. Available at: http://www.who.int/mediacentre/factsheets/fs230/en/ Last Accessed October 2017.   
[viii] Allergan Ltd. Ozurdex Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc Last Accessed October 2017.  
[ix] Royal College of Ophthalmologists. Retinal vein occlusion (RVO) interim guidelines. London: Royal College of Ophthalmologists, 2010.  
[x] Kuppermann B.D., Blumenkranz M.S., Haller J.A. et al. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Ophthalmol 2007;125:309–17. 
[xi] Manaviat M.R., Rashidi M. Intravitreal triamcinolone acetonide for macular edema in retinal vein occlusion. Int J Ophthalmol (GuojiYanke Zazhi) 2008;8:230–33.
[xii] Morley M.G., Heier J.S. Venous obstructive disease of the retina. In: Yanoff M, Duker JS (eds). Ophthalmology (3rd edn). Elsevier Mosby 2009:597–605.

CONTACTS: Allergan: 
Investors:  
Daphne Karydas 
(862) 261-8006

Media: 
Mark Marmur 
(862) 261-7558 
Janet Kettels 
+44 7738 506-476 
Bernie Ursell 
+44 7500 025-494

SOURCE Allergan plc

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