Alcon introduces Contoura Vision as first personalized LASIK procedure at American Academy of Ophthalmology Annual Meeting
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Alcon introduces Contoura Vision as first personalized LASIK procedure at
American Academy of Ophthalmology Annual Meeting
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* Nearly 65% of eyes treated with personalized topography-guided LASIK
experienced 20/16 vision or better[1] in clinical study
* Alcon is the first refractive laser manufacturer to receive FDA approval for
a topography-guided LASIK procedure
* Alcon to further showcase new data in glaucoma treatments, cataract as well
as refractive surgery procedures using Wavelight technology
Basel, November 15, 2015 - Alcon, the global leader in eye care and a division
of Novartis, will introduce Contoura Vision, the latest advancement in its
WaveLight refractive portfolio during the annual meeting of the American Academy
of Ophthalmology (AAO) in Las Vegas, November 14-17, 2015. Alcon will also
present new research findings in glaucoma, cataract and refractive surgical
procedures at AAO.
Building on its broad portfolio of ophthalmic surgical innovations, Contoura
Vision is a topography-guided LASIK treatment designed to provide surgeons the
ability to perform more personalized laser procedures for patients with
nearsightedness, or nearsightedness with astigmatism, based on the unique
corneal topography of each eye. In 2014, more than 630,000 LASIK procedures were
performed in the US alone.[2]
"We are pleased to provide surgeons with a technology that has been shown to
deliver visual acuity better than glasses or contact lenses for nearly one-third
of patient eyes in a clinical trial setting," said Franck Leveiller, Head of
Research & Development for Alcon's Surgical Franchise. "Backed by FDA approval
and very positive clinical trial outcomes, surgeons can now offer a topography-
guided treatment option for refractive surgery patients in the US."
Multicenter clinical trial results demonstrate that the personalized topography-
guided LASIK procedure Contoura Vision redefined the standard practice
terminology of "quality of vision" which is visual acuity combined with visual
symptoms, with more than 30% of eyes achieving better unaided visual acuity 12
months after surgery than with glasses or contact lenses prior to surgery.[1] In
this US-based clinical trial, 92.6% of eyes that received topography-guided
LASIK treatment achieved 20/20 vision or better: specifically, 64.8% experienced
20/16 vision or better, and 34.4% could see 20/12.5 or better, 12 months after
surgery. The procedure also showed statistically significant reductions in some
of the visual symptoms associated with LASIK, such as glare, light sensitivity,
difficulty driving at night and difficulty while reading.
Contoura Vision is performed with Alcon's WaveLight Allegretto Wave Eye-Q or
WaveLight EX500 Excimer Laser Systems, in conjunction with the WaveLight
Topolyzer Vario Diagnostic Device. Alcon plans for broad commercial release of
Contoura Vision in in the US in early 2016.
Alcon Scientific Results and Data Presentations during AAO
In addition to its Contoura Vision launch, Alcon will be presenting data and
clinical results for current pipeline and product innovations:
* Two Studies on Fixed Combination Brinzolamide 1%/Brimonidine 0.2% (BBFC)
used Adjunctive to Prostaglandin Analogs (PGAs): Findings show additive
effect of BBFC therapy in patients with open-angle glaucoma or ocular
hypertension who were inadequately controlled on PGA alone.
* A Study Comparing Intraoperative Aberrometry versus a Toric Calculator in
Determining Toric IOL Cylinder Power and Axis
* Refractive Outcomes in Post-hyperoptic LASIK Cataract Patients in which
Intraoperative Aberrometry was used to Determine IOL Power
* Postoperative Uncorrected Visual Acuity vs Preoperative Best Corrected
Visual Acuity with the WaveLight Refractive Suite
* Comparing Aphakic Refractive Measurements in Eyes in which BSS and an
ophthalmic viscosurgical device were used with an Intraoperative Aberrometer
For further details about Alcon presentations and poster sessions, please visit
the AAO meeting program schedule https://secure.aao.org/apps/.
Important Information about WaveLight Excimer Lasers
WaveLight Excimer Lasers are prescription medical devices that are approved for
use in performing laser-assisted in-situ keratomileusis (LASIK) to correct
certain kinds of nearsightedness (myopia), farsightedness (hyperopia), and
astigmatism. Only doctors who have been trained in laser refractive surgery
(including laser calibration and operation) should use a WaveLight Excimer
Laser.
Patients should not undergo LASIK surgery if they are pregnant or nursing; if
they have a collagen vascular, autoimmune or immunodeficiency disease; if they
show signs of keratoconus or any other condition that causes a thinning of the
cornea; or if they are taking isotretinoin (Accutane*) or amiodarone
hydrochloride (Cordarone*). The most common risks of LASIK vision correction
surgery with refractive lasers include dry eye syndrome; the possible need for
glasses or contact lenses after surgery; visual symptoms including halos, glare,
starbursts, and double vision; and loss of vision. Additional product
information can be found on the Laser website at www.alconsurgical.com.
*Trademarks are property of their respective owners.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "will," "scheduled," "portfolio," "plans," "promising,"
"pipeline," or similar terms, or by express or implied discussions regarding
potential future marketing approvals for Contoura Vision or the other Alcon
pipeline projects discussed in this release, or regarding potential future
revenues from Contoura Vision or the portfolio of Alcon pipeline projects and
marketed products discussed in this release. 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 Contoura Vision or
the other Alcon pipeline projects discussed in this release will be submitted or
approved for sale in any additional markets, or at any particular time. Nor can
there be any guarantee that Contoura Vision or the portfolio of Alcon pipeline
projects and marketed products discussed in this release will be commercially
successful in the future. In particular, management's expectations regarding
Contoura Vision and the portfolio of Alcon pipeline projects and marketed
products discussed in this release 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 issues; unexpected manufacturing or quality 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 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
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
http://twitter.com/novartis.
References
[1] FDA Clinical Trials. Allegretto Wave Eye-Q Addendum Procedure Manual T-CAT
Topography-Guided Treatments.
http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020050S012d.pdf
[2] MarketScope. Alcon data on file, 2015.
* Post hoc analysis of postoperative UCVA compared to preoperative BSCVA of 230
eyes contained in the FDA T-CAT pivotal trial at 12 months. The primary end
point evaluated changes in BSCVA
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Unternehmensinformation / Kurzprofil:
Datum: 15.11.2015 - 18:00 Uhr
Sprache: Deutsch
News-ID 434664
Anzahl Zeichen: 12460
contact information:
Town:
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Kategorie:
Business News
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