Alcon receives CE Mark for first-of-its-kind AutonoMe(TM) preloaded intraocular lens (IOL) delivery system with Clareon® IOL
(Thomson Reuters ONE) -
Novartis International AG /
Alcon receives CE Mark for first-of-its-kind AutonoMe(TM) preloaded intraocular
lens (IOL) delivery system with Clareon® IOL
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The issuer is solely responsible for the content of this announcement.
* AutonoMe(TM) preloaded IOL delivery system provides easy, intuitive control
for precise IOL insertion during cataract surgery
* New Clareon(®) IOL in vitro data and early clinical experience to be
presented at European Society of Cataract & Refractive Surgeons congress
Basel, October 6, 2017 - Alcon, the global leader in eye care and a division of
Novartis, has achieved European CE Mark for the Clareon(®) IOL with the
AutonoMe(TM) delivery system. AutonoMe(TM) is the first-and-only automated,
disposable, pre-loaded IOL delivery system that enables precise delivery of the
IOL into the capsular bag in patients undergoing cataract surgery[1-2]. The new
device is being introduced with the Clareon(®) IOL, a new BioMaterial with an
advanced design that enables sharp, crisp vision; low edge glare; and,
unsurpassed optic clarity[2]*. These new innovations, along with supporting
scientific data, will be presented at the XXXV congress of the European Society
of Cataract & Refractive Surgeons (ESCRS) taking place October 7 - 11 in Lisbon,
Portugal.
"With the introduction of Clareon(®) AutonoMe(TM), we are proud to unveil our
latest innovations to benefit doctors and their patients undergoing cataract
surgery," said Mike Ball, Chief Executive Officer, Alcon. "Throughout Alcon's
history, we have worked with doctors to enhance and transform the way cataract
surgery is performed. Clareon(®) AutonoMe(TM) builds upon the comprehensive
legacy of AcrySof(®) by offering cataract surgeons easy, intuitive control of
IOL delivery with the newest optic material."
The AutonoMe(TM) delivery system, preloaded with the Clareon(®) IOL, is designed
with advancements intended to benefit both surgeons and cataract patients. Its
automated CO(2)-powered delivery mechanism and intuitive, ergonomic design allow
precise and simplified single-handed control of IOL placement during cataract
surgery[1-2].
"Comfort and efficiency during the cataract surgery are key to achieving better
outcomes. This new device is expected to improve the procedure and ultimately to
reduce surgical time," said Prof. Rudolph Nuijts, University of Maastricht,
Netherlands. "This is great news for surgeons because Clareon(®) AutonoMe(TM)
provides a cutting-edge, intuitive and easy-to-use device that allows precise
and controlled IOL delivery."
The Clareon(®) hydrophobic acrylic IOL, which received CE Mark in May, is made
of a patented, innovative optic polymer material. Clareon(®) builds on and
maintains the benefits of the proven AcrySof(®) platform with a new optic
BioMaterial that offers cataract patients unsurpassed clarity[2]*.
Alcon will present new data on Clareon(®) via paper presentations and electronic
posters at ESCRS, including:
* Scientific Paper Presentation: Optical Purity Evaluation and Accelerated
Aging of the New Clareon(®) Biomaterial vs. Other Hydrophobic Acrylic
Material in a Laboratory Setup, Dr. G. Auffarth (Tuesday, October 10, 3:42 -
3:48 p.m., Room 3.6, FIL congress center)
* Scientific Paper Presentation: Evaluation of Clarity Characteristics in a
New Hydrophobic Acrylic IOL in Comparison with Commercially Available
Lenses, Dr. L. Werner, (Tuesday, October 10, 3:48p.m., Room 3.6, FIL
congress center)
* Electronic Poster: Model Eye and In Vitro Assessment of Positive
Dysphotopsia or Glare Types Photic Phenomena: A Comparison of a New Material
IOL to other Monofocal Intraocular Lenses, Dr. L. Werner
* Electronic Poster: Laboratory Evaluation of the New Clareon(®) Hydrophobic
Acrylic IOL Material: Biomaterial Properties and Capsular Bag Behaviour, Dr.
G. Auffarth
* Electronic Poster: Miyake-Apple Posterior View analysis of Capsular Bag
Behavior of the New Clareon(® )Hydrophobic Acrylic IOL Material, Dr. H. Fang
* Electronic Poster: Silicone Oil Adhesion of Hydrophobic Acrylic Intraocular
Lenses (IOL): A Comparative Laboratory Study of the New Clareon(®) Versus
Current AcrySof(®) IOL Material, Dr. F. Hengerer
* Electronic Poster: Evaluation of the Mechanical Behavior of a New Single-
Piece Intraocular Lens as Compared to Commercially Available IOLs, Dr. S.
Lane
Clareon(® )AutonoMe(TM) is expected to be commercially available to cataract
surgeons in the EU early next year. Learn more about these innovations at the
Alcon Booth #P272 in the exhibition area of the Feira Internacional de Lisboa
(FIL) congress center at ESCRS.
About Cataracts
A cataract is a clouding of the natural lens of the eye that affects vision. As
a cataract develops, the eye's lens gradually becomes harder and cloudy which
scatters light rays and allows less light to pass through it, thus reducing the
patient's ability to see. The vast majority of cataracts occur as part of normal
aging but radiation exposure, taking steroids, diabetes, and eye trauma can
accelerate the development of cataracts.
Additionally, cataracts can be hereditary and congenital and can present shortly
after birth[3]. Cataracts are the most common age-related eye condition and the
leading cause of preventable blindness in adults 55 and older[4]. Cataracts are
treated by surgically removing the eye's cloudy natural lens and replacing it
with an intraocular lens (IOL). More than 98 percent of cataract surgeries are
considered successful and patients can usually return to their normal routines
very soon after surgery[5].
Important Information About the Clareon® IOL with the AutonoMe(TM) Delivery
System
As with any surgical procedure, there is risk involved. Potential complications
accompanying cataract and/or IOL implantation surgery may include, but are not
limited to, the following: lens epithelial cell on-growth, corneal endothelial
damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid
macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse,
hypopyon, transient or persistent glaucoma. Surgeons should use careful
preoperative evaluation and sound clinical judgement to decide the benefit/risk
ratio before implanting a lens in a patient with one or more of the conditions
identified in the product labeling. Only Alcon-qualified ophthalmic
viscosurgical devices (OVDs) should be used with Clareon(®) AutonoMe(TM). The
use of an unqualified OVD may cause damage to the lens and potential
complications during the implantation process.
Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in this press
release, or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations 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 the
investigational or approved products described in this press release will be
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that such
products will be commercially successful in the future. In particular, our
expectations regarding such products 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; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions, including the
effects of the persistently weak economic and financial environment in many
countries; 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
119,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
1. Clareon® AutonoMe(TM) IOL Directions for Use.
2. Alcon data on file, 2017
3. NIH, NEI, Facts About Cataracts, September 2009. Available at:
http://www.nei.nih.gov/health/cataract/cataract_facts.asp (link is external)
4. National Institutes of Health (NIH), National Eye Institute (NEI), Eye
 Health Needs of Older Adults Literature Review, 2007. Available at:
http://www.nei.nih.gov/nehep/research/The_Eye_Health_needs_of_Older_Adults_
Literature_Review.pdf (link is external)
5. Eye Surgery Education Council, Cataract Surgery, accessed August 2013.
Available at: http://eyesurgeryeducation.org/surgery-optionscataract-
about.php
 (link is external)
*Based on aggregate results from in vitro evaluations of haze, SSNGs and
glistenings compared to TECNIS(§) OptiBlue(§) ZCB00V (Abbott),TECNIS(§) ZCB00
(Abbott), Eternity(§) Natural Uni W-60 (Santen), Vivinex(§) XY-1 (HOYA) and
enVista(§) MX60 (B&L; Bausch & Lomb).
(§ )Trademarks are the property of their respective owners
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Wes Warnock
Novartis Global Media Relations Alcon Global Communications
+41 61 324 7999 (direct) +1 817-615-2501 (direct)
+41 79 593 4202 (mobile) +1 210-240-4998 (mobile)
eric.althoff(at)novartis.com wes.warnock(at)alcon.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central  North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2139907/819288.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.10.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 562696
Anzahl Zeichen: 14698
contact information:
Town:
Basel
Kategorie:
Business News
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