- Latest addition to Alcon’s intraocular lens (IOL) portfolio
expands surgeons’ presbyopia-correcting IOL (PC-IOL)
offerings
- Vivity X-WAVE technology delivers extended range of vision
while maintaining a monofocal-like visual disturbance
profile*1,2
- PC-IOL option for cataract patients who may not be a
candidate for a diffractive IOL
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated
to helping people see brilliantly, has commercially launched the
first and only non-diffractive extended depth of focus intraocular
lens (IOL) in the U.S. – the AcrySof® IQ VivityTM IOL (Vivity).
This new presbyopia-mitigating lens is now available to all U.S.
ophthalmologists for patients undergoing cataract surgery.
Cataracts are the most common cause of vision loss globally.3 The
U.S. market is expected to grow to 5.4 million cataract surgeries
by 2025.4 With the aging population, the number of people in the
U.S. with cataracts is expected to double by 2050.3
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Vivity is a first-of-its-kind, non-diffractive extended depth of
focus IOL with Alcon’s proprietary non-diffractive X-WAVE™
technology, which stretches and shifts light without splitting it.1
Vivity delivers monofocal-quality distance (far) with excellent
intermediate (at arm’s length) and functional near vision (up
close).*2 The lens expands Alcon’s growing portfolio of
presbyopia-mitigating IOLs to meet the needs of cataract patients
who are interested in restoring their visual performance and
improving their lifestyle.
“With the introduction of Vivity, Alcon continues to demonstrate
our ongoing commitment to growing our IOL portfolio and delivering
differentiated innovations that meet surgeon and patient needs,”
said Sergio Duplan, President, North America at Alcon. “We now
offer two next-generation presbyopia-mitigating IOL options, with
the PanOptix Trifocal for patients who want to be more spectacle
independent at all distances and Vivity for patients who seek to
improve their intermediate and near vision, with a monofocal-like
visual disturbance profile.”
Also available in toric designs, Vivity is built on Alcon’s
trusted and proven AcrySof IQ IOL platform that has been implanted
in more than 125 million eyes globally.5 According to results from
a U.S. clinical trial, patients who had the Vivity lens implanted
experienced renewed vision and lifestyle benefits, including:2
- 94% and 92% of Vivity patients reported very good or good
vision at distance and arm’s length, respectively, without glasses
in bright light, with vision of 20/20 at distance and greater than
20/25 at intermediate*†2
- Comparable visual disturbance profile to a monofocal IOL*2
“The Vivity lens is a disruptive technology that fills a gap for
eye surgeons as a presbyopia-mitigating IOL option for those
patients who are not candidates for a diffractive IOL platform, but
want some spectacle independence,” said Dr. Cathleen McCabe, Chief
Medical Officer, Eye Health America and Medical Director, The Eye
Associates. “This lens has a monofocal-like visual disturbance
profile, a low incidence of severe or very bothersome glare and
halos, and provides a continuous extended range of vision which can
meet the needs of many cataract patients.”
Vivity received FDA approval in February 2020, and it was made
available to select U.S. ophthalmologists in September 2020 during
a pilot phase, ahead of the current national launch.
Vivity is already available in some European markets, Australia,
New Zealand and Canada and has been introduced to select
ophthalmologists in Latin America. For more information regarding
Vivity in the U.S., visit vivityview.com.
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
result from normal aging, but radiation exposure, taking steroids,
diabetes and eye trauma can accelerate their development.3
Cataracts are the most common age-related eye condition and the
leading cause of preventable blindness.6 Twenty million people in
the U.S. age 40 and older have cataracts.3 Cataracts are treated by
removing the eye’s cloudy natural lens and surgically replacing it
with an intraocular lens or IOL. More than 98 percent of cataract
surgeries are considered successful, and patients typically can
return to their normal routines within 24 hours.7
About Presbyopia
Presbyopia is a common, age-related vision condition in which
people have difficulty focusing on things up close. It involves the
gradual loss of the eye’s ability to focus on close objects, such
as smart phones, computers, books and menus.8 Almost everyone will
experience presbyopia to some degree as they age, with symptoms
often first appearing as an individual enters their 40s and
continues to worsen into their 60s.8 In the U.S., an estimated 112
million people experience vision issues due to presbyopia – a
number that’s expected to continue increasing.9 The condition is
not a disease, so it cannot be cured; however, there are safe and
effective ways to correct presbyopia, including eye glasses,
contact lenses or refractive surgery.
About the AcrySof® IQ
Vivity™
IOL
The non-diffractive AcrySof® IQ VivityTM Extended Vision
Posterior Chamber Intraocular Lens Model DFT015 (referred to as
AcrySof® IQ VivityTM IOL) is a UV-absorbing and blue light
filtering foldable intraocular lens (IOL). This IOL, compared to a
monofocal IOL, provides an extended range of vision from distance
to near without increasing the incidence of visual
disturbances.
Potential side effects: As with any surgery, there is an
implicit risk, whether or not the IOL is implanted. The
complications of the IOL implantation surgery ranges from minor
side effects (usually temporary) to serious complications. Patients
with previous illnesses or disorders (such as chronic infections of
the eye or eyelids, or diabetes) may present a higher risk of
complications. Temporary surgical complications include, but are
not limited to, reactions to medications such as irritation or mild
allergic response, bleeding, redness, itching of the eye,
sensitivity to light, swelling, corneal edema (swelling of the
cornea), problems with the iris, cell growth in the IOL, and an
increase temporary eye pressure. There is a small risk of needing
further surgical treatment (such as IOL replacement implanted by a
different one or surgery to improve vision) after the implantation
of the initial IOL.
ABOUT ALCON
Alcon helps people see brilliantly. As the global leader in eye
care with a heritage spanning more than seven decades, we offer the
broadest portfolio of products to enhance sight and improve
people’s lives. Our Surgical and Vision Care products touch the
lives of more than 260 million people in over 140 countries each
year living with conditions like cataracts, glaucoma, retinal
diseases, and refractive errors. Our more than 20,000 associates
are enhancing the quality of life through innovative products,
partnerships with eye care professionals and programs that advance
access to quality eye care. Learn more at www.alcon.com.
References
- Alcon Data on File, 2019.
- AcrySof® IQ Vivity™ Extended Vision IOL DFU. Alcon
Laboratories, Inc.; 2020.
- Cataract Data and Statistics. National Eye Institute. Accessed
December 21, 2020.
https://www.nei.nih.gov/learn-about-eye-health/resources-for-health-educators/eye-health-data-and-statistics/cataract-data-and-statistics.
- 2020 IOL Market Report – Mid Year Update, Market Scope,
08/28/2020, pp5, Table 47: Forecast for the IOL Market in the
United States.
- Alcon Data on File, 2020.
- Centers for Disease Control and Prevention, Vision Health
Initiative. Accessed December 21, 2020.
https://www.cdc.gov/visionhealth/basics/ced/index.html.
- Cleveland Clinic, Cataracts. Accessed December 21, 2020.
https://my.clevelandclinic.org/health/diseases/8589-cataracts.
- Mayo Clinic, Presbyopia. Accessed December 21, 2020.
https://www.mayoclinic.org/diseases-conditions/presbyopia/symptoms-causes/syc-20363328.
- American Optometric Association: Optometric Clinical Practice
Guideline, Care of the Patient with Presbyopia. Accessed December
21, 2020.
https://www.aoa.org/documents/optometrists/CPG-17.pdf.
*Results from a prospective, randomized, parallel group,
subject- and assessor-masked, multisite trial of 107 subjects
bilaterally implanted with the AcrySof® IQ Vivity™ IOL and 113 with
the AcrySof® IQ IOL with 6 months’ follow-up
†Response to the following question in IOLSAT questionnaire at 6
months post-op (AcrySof® IQ Vivity™ IOL n = 106, monofocal n =
111): “Given your vision today, would you recommend the lenses you
had implanted to your family or friends?”
Disclaimer
This press release contains
“forward-looking statements” within the meaning of the safe harbor
provisions of the United States Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
words such as: “anticipate,” “intend,” “commitment,” “look
forward,” “maintain,” “plan,” “goal,” “seek,” “believe,” “project,”
“estimate,” “expect,” “strategy,” “future,” “likely,” “may,”
“should,” “will” and similar references to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties and risks that
are difficult to predict. Some of these factors are discussed in
our filings with the United States Securities and Exchange
Commission, including our Form 20-F. Should one or more of these
uncertainties or risks materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated. Therefore, you should not rely on any of
these forward-looking statements.
Forward-looking statements in this press release speak only as
of the date of its filing, and we assume no obligation to update
forward-looking statements as a result of new information, future
events or otherwise.
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Investor Relations Christina
Cheng + 41 589 112 110 (Geneva) + 1 817 615 2789 (Fort Worth)
investor.relations@alcon.com
Media Relations Blake Overby
+ 1 817 551 4328 (Fort Worth) + 1 682 321 2897 (Fort Worth)
blake-1.overby@alcon.com
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