-
Alcon to host first live
training program on the use of the CyPass® Micro-Stent,
a minimally invasive glaucoma surgical device to treat cataract
patients with mild to moderate primary open-angle
glaucoma
-
Two-year safety and efficacy
data from landmark COMPASS study published in peer reviewed
journal Ophthalmology; data reinforcing
intraocular pressure (IOP)-lowering benefits of the CyPass
Micro-Stent to be presented at conference
The digital press
release with multimedia content can be accessed here:
Basel, October 17, 2016
- Alcon, the global leader in eye care and a
division of Novartis, announced the US launch of the
CyPass® Micro-Stent
at the annual meeting of the American Academy of Ophthalmology
(AAO), October 15-18 in Chicago, where Alcon will host a live
training program and present additional data during poster and oral
sessions. The CyPass Micro-Stent was approved by the US Food and
Drug Administration in July for use in conjunction with cataract
surgery to lower intraocular pressure in adult patients with mild
to moderate primary open-angle glaucoma.
"We are excited to launch the CyPass Micro-Stent
device in a new segment of glaucoma treatment called
minimally-invasive glaucoma surgery, or MIGS," says Sergio Duplan,
Region President, North America, Alcon. "This new treatment option
for cataract patients with mild to moderate primary open-angle
glaucoma has been demonstrated to have a lasting, significant
IOP-lowering effect."
The CyPass Micro-Stent device is implanted during
cataract surgery, just below the surface of the eye, into the
supraciliary space. It is designed to lower IOP by enhancing
aqueous outflow through one of the natural drainage pathways of the
eye, with minimal tissue disruption, which allows the excess fluid
in the eye to drain. The CyPass Micro-Stent was developed by
Transcend Medical, Inc. which Alcon acquired in February 2016.
As part of its activities at AAO, Alcon will
present two- and three-year data from COMPASS, the largest study of
MIGS to date, as well as three-year data findings from the CYCLE
study (a real-world registry study conducted in the EU).
-
Poster presentation.
Supraciliary Micro-Stent Implantation for Lowering IOP in Glaucoma
Patients Undergoing Cataract Surgery: Randomized, Controlled,
3-Year Results From a Single Center, presented by Dr. Steven D.
Vold. (Mon, Oct 17 from 12:30-2:00PM; Location: Hall A)
-
Poster presentation. Prognostic
Factors for Lowering IOP in Primary Open-Angle Glaucoma by Combined
Supraciliary Micro-Stenting-Phaco Cataract Surgery: COMPASS
Randomized Controlled Trial, presented by Dr. Tsontcho
Ianchulev (Sun, Oct 16 from 12:30-2:00pm; Location: Hall A)
-
Paper presentation. Minimally
Invasive Supraciliary Micro-stent for IOP Control in Combined
POAG-cataract Surgery: 2-year COMPASS RCT Results, presented by
Dr. Reay H. Brown. (Mon, Oct 17 from 3:52-3:59pm; Location:
S405)
-
Paper presentation. Multicenter
3-Year Results After Combined Cataract Surgery and Supraciliary
Micro-Stent Implantation for Open-Angle Glaucoma, presented by
Dr. Steven R. Sarkisian. (Mon, Oct 17 from 3:24-3:31pm; (Location:
S405)
Two-year data from the landmark COMPASS study was
also published recently in the online edition of the peer-reviewed
journal Ophthalmology. The data published in
Ophthalmology is a follow-up for over 500 mild
to moderate glaucoma patients who underwent cataract surgery. The
randomized clinical study demonstrated safe and sustained two-year
reduction in intraocular pressure and glaucoma medication use after
micro-interventional surgical treatment for mild-to-moderate
primary open-angle glaucoma.
"Findings from the COMPASS and CYCLE studies are
significant and further demonstrate Alcon's dedication to bringing
to market some of the most innovative surgical technologies to
effectively treat diseases like glaucoma," said Franck Leveiller,
Head of Global Research & Development, Alcon. "We are proud to
be working with glaucoma experts and surgeons in the US and around
the world to bring this new treatment option to as many eligible
patients as possible."
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.[1,2,3]
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 "launches," "to host," "to be
presented," "will," "excited," "launch," "dedication," "can," 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 118,000 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/(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] http://myeyes.com/glaucoma.shtml(link is external)
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