Alcon receives US FDA approval for new AcrySof® IQ ReSTOR® +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction
(Thomson Reuters ONE) -
Novartis International AG /
Alcon receives US FDA approval for new AcrySof® IQ ReSTOR® +2.5 Multifocal Toric
IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia
correction
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The issuer is solely responsible for the content of this announcement.
* 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 (at)Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-
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media.relations(at)novartis.com
* 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
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Roslyn Patterson
Novartis Global Media Relations Novartis Alcon Communications
+41 61 324 7999 (direct) + 1 817 615 5092 (direct)
+41 79 593 4202 (mobile) + 1 817 891 8104 (mobile)
eric.althoff(at)novartis.com roslyn.patterson(at)alcon.com
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Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.03.2017 - 07:15 Uhr
Sprache: Deutsch
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