--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.
References
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.
iv Royal 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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