-
The unique optical design of
the ACTIVEFOCUS(TM) toric IOL
gives astigmatic cataract patients quality distance vision and an
increased range of vision to potentially reduce dependence on
glasses
-
The lens is based on the proven
AcrySof® IQ toric IOL
platform that delivers unrivaled rotational
stability[1]
-
This extends the market-leading
AcrySof® IQ platform
to a broader population of the nearly 2 million cataract patients
with treatable levels of astigmatism who undergo cataract surgery
each year[2]
Basel, March 23, 2017 -
Alcon, the global leader in eye care and a division of Novartis,
has received approval from the US Food and Drug Administration
(FDA) for its AcrySof® IQ ReSTOR® +2.5 Multifocal Toric intraocular
lens (IOL) with ACTIVEFOCUS(TM) optical design for patients
undergoing cataract surgery who choose to address their astigmatism
and presbyopia at the same time. The unique optical design of the
ACTIVEFOCUS(TM) toric lens delivers both crisp, clear distance
vision and a range of vision for patients who desire less
dependence on glasses. The ACTIVEFOCUS(TM) toric IOL is the only
multifocal toric IOL in which the central portion is 100 percent
dedicated to distance vision[3],[4]. Previous presbyopia-correcting
IOL designs tend to compromise on distance vision in order to
provide patients with a range of vision.
"Presbyopic cataract patients with astigmatism
have had limited options in the past," said Sergio Duplan, Region
President, North America for Alcon. "Alcon's ACTIVEFOCUS(TM) toric IOL
is a breakthrough for these patients, correcting astigmatism and
allowing them to achieve uncompromised distance vision with an
increased range of vision at the same time."
The ACTIVEFOCUS(TM) toric IOL
is also engineered for stability. Toric IOLs perform optimally if
they stay on axis to correct the astigmatism. In a retrospective
study of IOL orientation data, the AcrySof® IQ
toric IOL platform was 2.5 times less likely to rotate than the
leading competitor lens*[1].
Additionally, the AcrySof® IQ toric
platform is the market leader with cataract surgeons implanting
more than 1.7 million AcrySof® IQ toric IOLs
to date[5].
"The ACTIVEFOCUS(TM) toric IOL
is the marriage of the design features of my two go-to IOLs for
patients wanting outstanding distance vision and less dependence on
glasses after cataract surgery," said Bret L.
Fisher, M.D., Medical Director, Eye Center of North
Florida. "By combining the unique optical properties of the
ACTIVEFOCUS(TM) design
with the unparalleled rotational stability of the
AcrySof® IQ toric
platform, I can now offer a range of vision to more patients."
Nearly four million cataract surgeries are
performed each year in the US, and more than 50 percent of those
patients have treatable levels of astigmatism that could be
addressed with AcrySof® IQ toric
IOLs[2], including the new ACTIVEFOCUS(TM) toric IOL.
Astigmatism occurs when the cornea is misshapen, causing blurry
vision and distorted images at all distances. Presbyopia occurs in
most people over the age of 40 and results in needing vision
correction such as reading glasses.
Alcon plans to commercialize the
ACTIVEFOCUS(TM) toric IOL
in the US beginning in mid-2017.
About Cataracts
A cataract is a cloudy area in the natural lens of the eye that
affects vision. As a cataract develops, the eye's lens gradually
becomes hard and cloudy allowing less light to pass through, which
makes it more difficult to see. The vast majority of cataracts
happen as a result of normal aging but radiation exposure, taking
steroids, diabetes, and eye trauma can accelerate the development
of cataracts[6]. Cataracts are the most common age-related eye
condition and the leading cause of preventable blindness[7]. Twenty
million people in the US age 40 and older have cataracts[8].
Cataracts are treated by removing the eye's cloudy natural lens and
surgically replacing it with an intraocular lens or IOL. More than
98% of cataract surgeries are considered successful and patients
typically can return to their normal routines within 24
hours[9].
About Astigmatism and
Presbyopia
Astigmatism is a variation in the shape or curvature of the cornea
and, if left untreated, can cause blurred vision at all distances.
Presbyopia is an eye condition that occurs as part of natural
aging. It involves the gradual loss of the eye's ability to
actively focus on close objects, such as smart phones, computers,
books and menus. The first signs of presbyopia are eyestrain,
difficulty seeing in dim light and problems focusing on small
objects and/or fine print. Once a person is in their 40s, it is
likely they will experience presbyopia and will require vision
correction such as reading glasses or multifocal contact
lenses.
Important
Information about AcrySof® IQ
ReSTOR® +2.5
Multifocal Toric IOL
Side effects associated with the AcrySof® IQ ReSTOR® +2.5 D
Multifocal Toric IOL include visual disturbances such as glare,
rings around lights, and blurred vision. These side effects may
make it more difficult to see while driving at night or completing
tasks in low lighting such as at night or in fog, after surgery as
compared to before surgery.
This IOL corrects corneal
astigmatism only when it is placed in the correct position in the
eye. There is a possibility that the IOL could be placed
incorrectly or could move within the eye. This may result in less
improvement or a reduction in vision because your corneal
astigmatism has not been fully corrected, or it may cause visual
symptoms.
The safety and effectiveness of
the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL has not been
established in patients with certain eye conditions, such as
glaucoma or diabetic retinopathy (an increase in eye pressure or
complications of diabetes in the eye).
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "potentially," "offer," "could,"
"plans," "can," "may," "likely," "will," or similar terms, or by
express or implied discussions regarding potential additional
marketing approvals for the AcrySof IQ ReSTOR +2.5 Multifocal Toric
IOL, or regarding potential future revenues from the AcrySof IQ
ReSTOR +2.5 Multifocal Toric IOL. 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 AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL 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
ReSTOR +2.5 Multifocal Toric IOL will be commercially successful in
the future. In particular, management's expectations regarding the
AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL 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; 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; 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 118,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow
@Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit
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* 1.86% by estimated market
usage, n=1,953 vs. 0.75% by estimated market usage, n=3,556.
References
[1] Potvin R, Kramer BA, Hardten DR, Berdahl JP.
Toric intraocular lens orientation and residual refractive
astigmatism: an analysis. Clin Ophthalmol.
2016;10:1829-1836.
[2] Provided courtesy of Dr. Warren Hill.
Accessed March 2017. Available at
http://www.doctor-hill.com/iol-main/astigmatism_chart.htm.
[3] Alcon Data on File. TDOC-0052151 (11 Apr
2016).
[4] Alcon Data on File. TDOC-0053021 (06 Oct
2016).
[5] Alcon Data on File. 2017.
[6] American Optometric Association (AOA),
Causes of cataract. Accessed August
2015. Available at:
http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/cataract?sso=y
[7] World Health Organization (WHO), Causes of blindness and visual impairment: cataract.
Accessed May 2016. Available at:
http://www.who.int/blindness/causes/en
[8] Centers for Disease Control and Prevention
(CDC), Common Eye Disorders, Accessed August
2015. Available at:
http://www.cdc.gov/visionhealth/basics/ced/index.html
[9] Cleveland Clinic. Cataracts. Accessed August 2015. Available
at:
http://my.clevelandclinic.org/services/cole-eye/diseases-conditions/hic-cataracts
# # #
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