Alcon receives European Approval for pre-loaded intraocular lens delivery system to treat patients undergoing cataract surgery
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Novartis International AG /
Alcon receives European Approval for pre-loaded intraocular lens delivery system
to treat patients undergoing cataract surgery
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* AcrySof(®) IQ Aspheric Intraocular Lens (IOL) with UltraSert(TM) Pre-loaded
Delivery System helps to maintain the integrity of the incision while
facilitating smooth, consistent delivery of the IOL
* Following recent European approval of trifocal presbyopia-correcting IOL,
single-use delivery system further expands the Alcon portfolio for cataract
surgery
Basel, July 1, 2015 - Alcon, the global leader in eye care and a division of
Novartis, has received European CE Mark for its AcrySof(®) IQ Aspheric IOL with
the UltraSert(TM) Pre-loaded Delivery System for patients undergoing cataract
surgery. The new delivery system combines the control of a manually loaded
device with the safety and convenience of a disposable, pre-loaded injector to
optimize implantation of the AcrySof IQ Aspheric IOL. This approval follows the
recent CE Mark for Alcon's trifocal presbyopia-correcting AcrySof IOL which was
received in mid-June. More than three million cataract surgeries are performed
each year in Europe[1].
"Alcon is committed to advancing cataract surgery through the continuous
development of new technologies and processes," said Franck Leveiller, PhD.,
Alcon Surgical Head of Research & Development. "Every detail of the UltraSert
Pre-loaded Delivery System has been engineered with the needs of surgeons,
technicians and the outcomes for their patients in mind. By simplifying the
device preparation and maximizing surgeon control in a single-use system, we
have cleared the path for more streamlined procedures and potentially improved
patient outcomes."
In cataract surgery, controlling the rate of delivery of the IOL when inserted
into the eye is an important factor in achieving a successful cataract
procedure. Alcon has addressed this factor in the UltraSert Pre-loaded Delivery
System with the TensionGlide(TM) Plunger, a spring-controlled mechanism designed
for a smooth, controlled delivery of the AcrySof IQ IOL into the capsular
bag[2]. In addition, the UltraSert Pre-loaded Delivery System features a plunger
tip which is designed to support consistent IOL folding and precise placement of
the IOL into the capsular bag of the eye[3],[4].
The design of the new UltraSert Pre-loaded Delivery System also helps to create
a less invasive corneal incision during cataract surgery. The smaller nozzle tip
allows for a corneal incision down to 2.2 mm[4] for insertion of the IOL while
the Depth Guard(TM) nozzle feature of the delivery system prevents the device
from being inserted deeper into the incision than necessary, preserving the size
of the original corneal incision[2].
"It is truly a step forward in pre-loaded delivery system technology," said
Khiun Tjia, MD, Senior Ophthalmologist, Isala Clinics, Zwolle, Netherlands.
"Featuring an impressive array of innovations, the UltraSert System acts as an
extension of the surgeon during the critical moment of implantation. It helps to
maintain the integrity of the incision while facilitating smooth, consistent
delivery of the proven AcrySof IQ Aspheric IOL."
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[5]. Additionally, cataracts can be
hereditary and congenital and can present shortly after birth[6]. Cataracts are
the most common age-related eye condition and the leading cause of preventable
blindness in adults 55 and older[7]. 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 within 24 hours[8].
Important Information about the UltraSert Pre-loaded Delivery System
As with any surgical procedure, there is risk involved. Potential complications
accompanying cataract or implant surgery may include corneal endothelial damage,
endophthalmitis, retinal detachment, vitritis, cystoid macular edema, corneal
edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, and
transient or persistent glaucoma. Only Alcon qualified viscoelastic(s) should be
used with the UltraSert Pre-loaded Delivery System. The use of an unqualified
viscoelastic may cause damage to the lens and potential complications during the
implantation process.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "committed," "cleared the path," "potentially," "may," or
similar terms, or by express or implied discussions regarding potential
additional marketing approvals for the UltraSert Pre-loaded Delivery System, or
regarding potential future revenues from the AcrySof IQ Aspheric IOL with
UltraSert Pre-loaded Delivery System or other products with the UltraSert Pre-
loaded Delivery System. 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 the UltraSert Pre-
loaded Delivery System will be submitted or approved for sale in any additional
markets, or at any particular time. Nor can there be any guarantee that the
AcrySof IQ Aspheric IOL with UltraSert Pre-loaded Delivery System or other
products with the UltraSert Pre-loaded Delivery System will be commercially
successful in the future. In particular, management's expectations regarding the
AcrySof IQ Aspheric IOL with UltraSert Pre-loaded Delivery System or other
products with the UltraSert Pre-loaded Delivery System could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of existing
clinical data; 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 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] Market Scope, 2014 Comprehensive Report on The Global IOL Market, May 2014.
[2] UltraSert(TM) Delivery System Prototype Human Factor Testing, February 2015.
[3] AcrySof® IQ UltraSert(TM) Preloaded Delivery System Directions for Use.
[4] Comparative Assessment of IOL Delivery Systems. Alcon internal technical
report: TDOC-0018957. Effective Date 19 May 2015.
[5] NIH, NEI, Facts About Cataracts, September 2009. Available at:
http://www.nei.nih.gov/health/cataract/cataract_facts.asp
[6] Riley AF, Grupcheva CN, Malik TY, Craig JP, McGhee CN. The Auckland Cataract
Study: demographic, corneal topographic and ocular biometric parameters. Clin
Experiment Ophthalmol. 2001; 29:381-6.
[7] 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_Liter
ature_Review.pdf
[8] Eye Surgery Education Council, Cataract Surgery, accessed August 2013.
Available at: http://eyesurgeryeducation.org/surgery-optionscataract-about.php
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Datum: 01.07.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 404128
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