ABBOTT PARK, Ill., July 15, 2016
/PRNewswire/ -- Abbott announced today that the U.S. Food and
Drug Administration (FDA) has approved the Tecnis
Symfony® Intraocular Lenses for the treatment of
cataracts. The first in a new category of intraocular lenses
(IOLs), the Tecnis Symfony lenses are the only lenses in
the United States that provide a
full range of continuous high-quality vision following cataract
surgery, while also mitigating the effects of presbyopia by helping
people focus on near objects. The FDA approval includes a version
of the lens for people with astigmatism, the Tecnis Symfony Toric
IOL.
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Cataracts are a common condition, with almost 4 million cataract
surgeries performed each year, and that number is expected to
increase.1 By age 80, more than half of all Americans
either have a cataract or have had cataract surgery.2
However, cataracts do not just impact seniors. In 2016 it is
estimated that nearly one in four cataract surgeries will be
performed on people younger than 65.1 Many people who have
cataracts experience other problems with their vision, such as
presbyopia and astigmatism, which the Symfony lenses also address.
Presbyopia, which affects most people over age 40, means people
have lost the ability to focus on objects up close and often
require glasses to perform near visual tasks. Astigmatism is when
the cornea is misshapen, which causes blurry or distorted
vision.
"The Symfony intraocular lens is a new option I can offer my
patients to improve their vision following cataract surgery,
especially those who have difficulty focusing on objects at near
distances because of presbyopia," said Eric
D. Donnenfeld, M.D., of Ophthalmic Consultants of Long
Island, New York. "Many of my
patients live very active lifestyles and want to see clearly at all
distances, and without glasses if possible. With the Symfony lens,
I can give patients the freedom to enjoy the activities that matter
to them, while wearing glasses less."
During cataract surgery, the natural lens of the eye is removed,
and an artificial lens, called an intraocular lens, or IOL, is
inserted into the eye. The IOL most commonly used in cataract
surgery is a monofocal lens, which only allows the person to see at
a distance, with closer objects being out of focus. In contrast,
the Symfony lens was specifically developed with features to
improve both the range and quality of vision.
"Abbott is focused on improving people's vision and their lives
by helping them stay healthy and active. Symfony offers patients,
including those with astigmatism, an option for crisp, clear vision
at all distances," said Thomas
Frinzi, senior vice president of Abbott's vision business.
"This is an important addition to our portfolio of lenses, as we
expect many patients to choose a Symfony lens over a standard
monofocal lens, given its benefits. We are happy that we can offer
more people around the world this new category of lenses."
The approval was based on results of a U.S. pivotal study that
compared the Tecnis Symfony lens to a Tecnis aspheric monofocal
lens in 298 patients. Compared with patients in the monofocal
group, those who received a Tecnis Symfony IOL achieved greater
improvements in intermediate and near vision while maintaining
similar distance vision. Patients in the Symfony group were also
more likely to achieve reduced overall spectacle wear and high
overall visual performance in any lighting condition. Rates of
adverse events did not differ between the Symfony and monofocal
groups.
The Symfony lens is approved in more than 50 countries around
the world, and has been widely studied, with data from numerous
clinical studies involving over 2,000 eyes. In clinical studies,
the Symfony lens:
- Provided seamless, day-to-night vision. Patients could
see objects sharply and clearly at near, intermediate and far away
distances, and points in between.
- Provided high-quality vision. Some IOLs may leave
patients with an inability to focus clearly due to competing
wavelengths of light passing through the lens at different angles
(known as chromatic aberration), or with vision that is not
completely focused because of the shape of the lens (known as
spherical aberration). The Symfony lens has been engineered to
correct these issues.
- Demonstrated a low incidence of halo and glare, which
may be perceived as rings or blurring around bright lights. Glare
and halo can sometimes affect an individual's ability to drive at
night or to perform other visual tasks.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS
SYMFONY AND TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION
IOLs
CAUTION: Federal law restricts this device to sale
by or on the order of a physician.
INDICATIONS FOR USE: The TECNIS Symfony IOL, Model ZXR00,
is indicated for primary implantation for the visual correction of
aphakia in adult patients with less than 1 diopter of pre-existing
corneal astigmatism in whom a cataractous lens has been
removed. The lens mitigates the effects of presbyopia by
providing an extended depth of focus. Compared to an aspheric
monofocal IOL, the lens provides improved intermediate and near
visual acuity while maintaining comparable distance visual acuity.
The Model ZXR00 IOL is intended for capsular bag placement
only.
The TECNIS Symfony Toric IOLs, Models ZXT150, ZXT225, ZXT300 and
ZXT375, are indicated for primary implantation for the visual
correction of aphakia and for reduction of residual refractive
astigmatism in adult patients with greater than or equal to 1
diopter of preoperative corneal astigmatism in whom a cataractous
lens has been removed. The lens mitigates the effects of presbyopia
by providing an extended depth of focus. Compared to an
aspheric monofocal IOL, the lens provides improved intermediate and
near visual acuity while maintaining comparable distance visual
acuity. The Model Series ZXT IOLs are intended for capsular
bag placement only.
CONTRAINDICATIONS: None.
RISKS: Routine cataract surgery risks, irrelevant to lens
selection, could be minor, temporary, or affect patients' vision
permanently. Rare complications are worsening of vision, bleeding,
or infection. Risks related to use of this lens include a slight
loss in vision sharpness with decreased use of glasses. Even with
glasses, loss of sharpness may worsen under poor visibility
conditions such as dim light or fog. This may lead to driving
difficulties, and not detecting road hazards as quickly at night or
in fog. Patients may also notice halos, starbursts, glare, and
other visual symptoms with extended range of vision IOLs. This may
impact patients when there are bright lights at night. Patients
should discuss all risks and benefits with their eye doctor before
surgery.
WARNINGS: A small number of patients may want their
TECNIS Symfony IOL removed because of lens-related optical/visual
symptoms. Patients with pre-existing diseases or conditions (i.e.,
diabetes and heart disease) may have higher risk of experiencing
complications (e.g., more difficult recovery) after routine
cataract surgery. Patients should not receive this lens if they
have had previous trauma to their eye. Not evaluated for use in
children.
PRECAUTIONS: If the patient's eye is unhealthy (including
glaucoma), vision may not be good even after cataract removal;
patients may not get full benefit of the TECNIS IOL. Before
surgery, the eye doctor will check for any eye diseases. Patients'
vision with the TECNIS Symfony IOL may not be good enough to
perform detailed 'up-close' work without glasses, and rarely, may
make some types of retinal treatment (e.g., retinal tear repair)
more difficult. Patients should take all prescribed medicines
and apply eye drops as instructed to avoid inflammation and
infection. Patients should avoid bending down and playing sports,
which can harm the eye during recovery. The eye doctor will tell
patients what activities to avoid.
SERIOUS ADVERSE EVENTS: Serious adverse events observed
during the TECNIS Symfony clinical trial were not related to the
lenses. These events included swelling of the retina,
inflammation and secondary surgeries.
About Abbott:
At Abbott, we're committed to helping
you live your best possible life through the power of health. For
more than 125 years, we've brought new products and technologies to
the world – in nutrition, diagnostics, medical devices and branded
generic pharmaceuticals – that create more possibilities for more
people at all stages of life. Today, 74,000 of us are working to
help people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter at @AbbottNews and
@AbbottGlobal.
1 2016 Comprehensive Report on the Global IOL Market,
Market Scope®, LLC.
2 National Eye Institute. Facts About Cataracts.
Available at: https://nei.nih.gov/health/cataract/cataract_facts.
Accessed July 1, 2016.
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SOURCE Abbott