Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical device to treat glaucoma
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Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical
device to treat glaucoma
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* US Food and Drug Administration (FDA) grants approval for CyPass Micro-Stent
for sale in the US, expanding Alcon's surgical presence to treat glaucoma
* The CyPass Micro-Stent is designed to reduce intraocular pressure in
patients with mild to moderate primary open-angle glaucoma
* More than 60 million people worldwide are affected by glaucoma which may
lead to progressive vision loss[1],[2]
Basel, August 2, 2016 - Alcon, the global leader in eye care and a division of
Novartis, announced today that it has achieved FDA approval for the CyPass(®)
Micro-Stent, a micro invasive glaucoma surgical (MIGS) device to treat patients
with mild to moderate primary open-angle glaucoma in conjunction with cataract
surgery. CyPass Micro-Stent is the latest addition to Alcon's surgical portfolio
providing an additional option to meet the needs of millions of glaucoma
patients.
The FDA approval is based on the landmark COMPASS Study, the largest MIGS study
to date with a two-year follow-up for over 500 mild to moderate glaucoma
patients undergoing cataract surgery. The primary effectiveness endpoint was
met, with 73% in the CyPass Micro-Stent study group achieving a statistically
significant decrease (>= 20%) in intraocular pressure (IOP).
The secondary effectiveness endpoint was also met, with 61% of patients in the
CyPass study group achieving a target IOP (between 6 and 18 mmHg) at the 24-
month postoperative examination without medication, which is a statistically
significant difference.
"We are pleased by the FDA's decision to approve our CyPass Micro-Stent which
establishes Alcon's presence in this emerging surgical category to treat mild to
moderate glaucoma," said Mike Ball, CEO of Alcon. "It will provide a less
invasive means of lowering IOP than traditional glaucoma surgery, with the goal
of lowering the patient's dependence on topical glaucoma medication. We are
excited to offer this new option to surgeons and the patients they serve."
Acquired in February 2016 by Alcon, Transcend Medical, Inc. developed the CyPass
Micro-Stent to treat mild to moderate primary open-angle glaucoma. The MIGS
device is implanted just below the surface of the eye in conjunction with
cataract surgery. It is designed to treat less severe glaucoma by enhancing part
of the natural drainage pathways of the eye with minimal tissue disruption. This
allows the excess fluid in the eye to drain with the goal of reducing
intraocular pressure levels.
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]-[3]
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 IOP in adult
patients with mild to moderate primary open-angle glaucoma. The use of the
CyPass Micro-Stent is contraindicated in eyes with angle closure glaucoma and
eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible
congenital anomalies of the anterior chamber angle. If IOP is not adequately
maintained after implantation of a CyPass Micro-Stent, additional therapy may be
needed for IOP control.
In a randomized, multicenter clinical trial comparing cataract surgery with
CyPass to cataract surgery alone, the most common post-operative adverse events
included: Best Corrected Visual Acuity (BCVA) loss of 10 or more letters at 3
months after surgery (8.8% for CyPass vs. 15.3% for cataract surgery only);
anterior chamber cell and flare requiring steroid treatment 30 or more days
after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5
or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more
days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after
surgery, or severe in nature (3.5% vs. 1.5%). Please refer to the Instructions
for Use for the CyPass Micro-Stent for a complete list of contraindications,
warnings, precautions and adverse events.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "may," "portfolio," "emerging," "will," "goal," "excited,"
"offer," 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
unexpected clinical trial results and additional analysis of existing clinical
data; unexpected 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 pressures;
unexpected 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 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,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 119,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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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/.
[2] Quigley and Broman. The Number of People with Glaucoma Worldwide in 2010 and
2020. Br J Ophthalmol 2006;90:262-7.
[3] http://myeyes.com/glaucoma.shtml
# # #
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Datum: 02.08.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 486646
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Town:
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