-
Now available in the UK,
Germany, Italy and Spain, CyPass Micro-Stent is designed to
significantly reduce intraocular pressure (IOP)
-
CE indication has been expanded
to allow patients to be treated at the time of cataract surgery
without the requirement of failed medical therapy
-
More than 60 million people
worldwide are affected by glaucoma, the leading cause of
irreversible blindness worldwide[1][2][3].
BASEL, April
26, 2017 - Alcon, the global leader in eye care and a division
of Novartis, announced today the EU launch of the CyPass®
Micro-Stent, a micro invasive glaucoma surgical (MIGS) device,
indicated for the treatment of patients with mild to moderate
primary open-angle glaucoma in conjunction with cataract surgery,
or as a standalone procedure in patients with primary open-angle
glaucoma who have failed previous medical treatments. The CyPass
Micro-Stent is the latest addition to Alcon's surgical glaucoma
portfolio providing an additional option to meet the needs of
millions of glaucoma patients.
"For many glaucoma patients, medication adherence
can be challenging due to side effects, difficulty administering
drops and the number of medications required daily. Even with
proper compliance, patients often have disease progression and
require surgery," said Keith Barton, M.D., glaucoma specialist at
Moorfields Eye Hospital in London. "The CyPass Micro-Stent is a
much-needed new option that is less invasive than traditional
glaucoma surgery. More importantly, it is available to patients
with mild to moderate glaucoma who are undergoing cataract surgery,
even if they have not yet failed previous medical treatments for
their glaucoma."
The CyPass Micro-Stent, implanted just below the
surface of the eye, is uniquely designed to reduce intraocular
pressure (IOP) in patients with primary open-angle glaucoma. The
CyPass Micro-Stent is the first MIGS device to leverage an entirely
new outflow pathway for excess aqueous fluid in the eye - the
supraciliary space, which is the space between the sclera, the
white outer layer of the eyeball, and the ciliary body. Once
implanted, it creates a permanent conduit between the anterior
chamber of the eye and the suprachoroidal space to improve the
eye's natural drainage pathway.
"The CyPass Micro-Stent is designed to address the
greatest unmet need in glaucoma treatment, reducing patient burden
by lowering dependence on topical glaucoma medicine," said Ian
Bell, Region President, Europe, Middle East and Africa for Alcon.
"We're pleased to offer the CyPass Micro-Stent as a valuable new
surgical treatment option for providers and patients in four EU
countries, further expanding Alcon's leadership in glaucoma and
surgical ophthalmology."
The CyPass Micro-Stent is now available in the UK,
Germany, Italy and Spain. Alcon launched the CyPass Micro-Stent in
the US last October and plans to train and certify over 500
surgeons in 2017.
About Glaucoma
More than 60 million people globally are affected by
glaucoma that can lead to progressive damage of the optic nerve.
Early diagnosis of glaucoma is critical to manage the disease, as
it is often asymptomatic and therefore can go undetected until it
is at an advanced stage. As the disease progresses, patients may
experience loss of peripheral (side) vision, tunnel vision or eye
spots. Glaucoma can eventually result in gradual, irreversible loss
of vision and blindness. The exact cause of glaucoma is unknown.
However, elevated pressure in the eye (intraocular pressure, or
IOP) is generally present with glaucoma and is the only known
modifiable risk factor. As a chronic disease, patients can be
treated with eye drops, oral medications, laser surgery,
traditional surgery or a combination of these methods[1][2][4].
About the CyPass
Micro-Stent
The CyPass Micro-Stent is a
prescription medical device that is indicated for use in
conjunction with cataract surgery for the reduction of intraocular
pressure (IOP) in adult patients with mild to moderate primary
open-angle glaucoma, or for use in cataract surgery or as a
standalone procedure for the reduction of IOP in adult patients
with primary open-angle glaucoma where previous medical treatments
have failed. Use of the CyPass® Micro-Stent is
contraindicated in eyes with angle closure glaucoma, in eyes with
traumatic, malignant, uveitic or neovascular glaucoma or
discernible congenital anomalies of the anterior chamber angle and
in patients with known intolerance or hypersensitivity to topical
anesthetics, miotics, mydriatics or polyimide. The surgeon should
monitor the patient postoperatively for proper maintenance of
IOP. If IOP is not adequately maintained after implantation
of a CyPass Micro-Stent, additional therapy may be needed for IOP
control.
Please refer to the Instructions for Use for the
CyPass Micro-Stent for a complete list of contraindications,
warnings, and precautions.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "launch," "portfolio," "offer,"
"plans," "can," "may," or similar terms, or by express or
implied discussions regarding potential additional approvals for
the CyPass Micro-Stent, or regarding potential future revenues from
CyPass Micro-Stent. You should not place undue reliance on these
statements. Such forward-looking statements are based on the
current beliefs and expectations of management regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that CyPass
Micro-Stent will be submitted or approved for sale in any
additional markets, or at any particular time. Nor can there be any
guarantee that CyPass Micro-Stent will be commercially successful
in the future. In particular, management's expectations regarding
CyPass Micro-Stent could be affected by, among other things, the
uncertainties inherent in research and development, including
clinical trial results and additional analysis of existing clinical
data; regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry
conditions; global trends toward health care cost containment,
including ongoing pricing and reimbursement pressures; safety,
quality or manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Novartis is providing
the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About Alcon
Alcon is the global leader in eye care. As a division of Novartis,
we offer the broadest portfolio of products to enhance sight and
improve people's lives. Our products touch the lives of more than
260 million people each year living with conditions like cataracts,
glaucoma, retinal diseases and refractive errors, and there are
millions more who are waiting for solutions to meet their eye care
needs. Our purpose is reimagining eye care, and we do this through
innovative products, partnerships with eye care professionals and
programs that enhance access to quality eye care. Learn more at
www.alcon.com.
Alcon is on Facebook. Like us at
www.facebook.com/AlconEyeCare
About Novartis
Novartis provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 118,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow
@Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit
www.novartis.com/news/media-library
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# # #
References
[1] Lighthouse International. Prevalence of Vision Impairment.
http://www.lighthouse.org/research/statistics-on-vision-impairment/prevalence-of-vision-impairment/
(link is external).
[2] Quigley and Broman. The Number of People with Glaucoma
Worldwide in 2010 and 2020. Br J Ophthalmol
2006;90:262-7.
[3] Richter and Coleman. Minimally invasive glaucoma surgery:
current status and future prospects. Clin Ophthalmol. 2016; 10:
189-206.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734795/
[4] http://myeyes.com/glaucoma.shtml (link is external)
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