Alcon launches the CyPass® Micro-Stent at the American Academy of Ophthalmology (AAO) 2016 annual meeting
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Novartis International AG /
Alcon launches the CyPass® Micro-Stent at the American Academy of Ophthalmology
(AAO) 2016 annual meeting
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The issuer is solely responsible for the content of this announcement.
* 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)
* Key finding: The CyPass Micro-Stent implantation at the time of cataract
surgery decreased unmedicated and medicated IOP from baseline and
sustained the lower IOP pressure through 36 months.
* 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)
* Key finding: The CyPass Micro-Stent implanted during cataract surgery
demonstrated sustained reduction in IOP at 24 months in patients with
mild-to-moderate primary open-angle glaucoma.
* 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)
* Key finding: Supraciliary microstenting in combination with cataract
surgery demonstrated sustained benefit after cataract surgery over two
years.
* 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)
* Key finding: Study results showed sustained control of IOP for 3 years
postoperatively.
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.
Novartis is on Twitter. Sign up to follow (at)Novartis at
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For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
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)
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Roslyn Patterson
Novartis Global Media Relations Alcon Communications
+41 61 324 7999 (direct) +1 817 615 5092 (direct)
+41 79 593 4202 (mobile) +1 817 891 8104 (mobile)
eric.althoff(at)novartis.com roslyn.patterson(at)alcon.com
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Media release (PDF):
http://hugin.info/134323/R/2049451/766462.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 17.10.2016 - 23:00 Uhr
Sprache: Deutsch
News-ID 500998
Anzahl Zeichen: 13582
contact information:
Town:
Basel
Kategorie:
Business News
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