NEW ORLEANS, May 8, 2016 /PRNewswire/ -- Today Abbott
(NYSE: ABT) announced that its pivotal clinical trial of the
company's Tecnis® Symfony 1-Piece Acrylic Intraocular
Lens (IOL) met its primary endpoint of improved intermediate
vision. Data from this study showed that people who received
the Tecnis Symfony lens achieved significantly improved
intermediate, as well as near, vision compared to those who
received a monofocal IOL. The data were presented today at
the American Society of Cataract and Refractive Surgery (ASCRS) in
New Orleans by Jason Jones, M.D., Jones Eye Clinic,
Sioux City,
Iowa.
"Many people with cataracts are asking for an option that will
help them perform near activities like reading, use their computers
and tablets at intermediate distance, as well as see objects that
are far away," said Dr. Jones, an investigator on the study. "The
data from this study showed that patients who received the Symfony
lens were more likely to achieve improved intermediate and near
vision, while maintaining similar distance vision compared with
patients who received a standard IOL."
A cataract is a condition in which the lens inside the eye
becomes cloudy. Many patients notice the symptoms of a
cataract as cloudy or blurred vision, faded color patterns, poor
night vision, doubling of images or frequent need to change their
glasses prescription.
Cataract surgery is one of the safest and most common surgeries
performed by eye surgeons, with almost 4 million surgeries
performed in the U.S. every year. That number is expected to grow
significantly as the population ages and as new lens choices are
introduced that provide people more options for improving their
vision and maintaining their active lifestyle after cataract
surgery. Though common in older adults, demographics are changing
among cataract patients. In 2016 it was estimated that 900,000
cataract procedures would be performed on people in the United States younger than 65 years
old.1
Unlike monofocal IOLs that provide a fixed focus point at one
particular distance, the Tecnis Symfony IOL has proprietary optical
features designed to elongate the range of focus of the eye and
provide a continuous range of vision at near, intermediate and
distance. The Symfony IOL has been widely studied, with data
from more than seven studies in over 2,000 eyes being collected.
The Symfony IOL is approved in more than 50 countries around the
world. In the U.S., it is an investigational lens and is not
available for commercial use.
"Today, people with cataracts want the ability to choose a lens
that is likely to give them the vision they want so they can
continue to be active and lead fulfilling lives," said Thomas Frinzi, senior vice president of Abbott's
vision business. "The existing Tecnis family of IOLs offers
personalized options for patients. The Symfony data presented at
ASCRS will be used to support our regulatory application for the
lens in the U.S., potentially providing even more choices to
doctors and patients."
About the study
The clinical trial was a prospective, multicenter, bilateral,
randomized, subject- and evaluator-masked clinical investigation
conducted at 15 U.S. sites. It evaluated the safety and
effectiveness of the Tecnis Symfony 1-Piece Acrylic IOL in 148
patients compared with 150 patients who received a Tecnis 1-piece
Aspheric Acrylic (monofocal) IOL. The study had two primary
endpoints: uncorrected intermediate visual acuity (monocular UCIVA)
in one eye, which is a measurement of how well the eye can focus at
intermediate distances without the aid of glasses or contacts; and
distance corrected intermediate visual acuity (monocular DCIVA) at
66 cm in one eye, which is a measurement of the best possible
vision at 66 cm with the use of distance glasses or contacts. Both
of these primary endpoints were met, and these data will be used to
support the regulatory application of the Tecnis Symfony IOL in the
U.S.
Key findings from the trial reported by Dr. Jones at ASCRS
include:
- At 6 months of follow-up, patients in the Symfony group
achieved 1.7 more lines of UCIVA and 2.4 additional lines of DCIVA
at 66 cm than patients in the monofocal group.
- With and without correction for distance vision, Symfony IOL
patients achieved an average binocular intermediate visual acuity
of 20/20.
- People who received the Symfony lens gained 2.2 more lines of
distance-corrected near visual acuity (DCNVA) compared with those
in the monofocal group.
- People who received the Symfony lens achieved significantly
better monocular near vision compared to those in the monofocal
group. When testing both eyes together, mean visual acuity at near
without correction was between 20/25 and 20/30.
- Rates of adverse events did not differ between the Symfony IOL
and monofocal group.
Data were also presented at ASCRS by James Loden, M.D., Loden Vision Center,
Nashville, Tenn., from four
prospective, multicenter clinical studies, for a total of 1,464
eyes (of 735 individuals) from 69 sites in Europe, New
Zealand and the U.S. These results showed that the
Symfony lens was associated with low levels of glare, halo and
starburst. High levels of patient satisfaction were also achieved
in Symfony clinical trials: More than 91 percent of patients
(N=589) in the studies said they would choose the Symfony lens
again, and more than 93 percent (N=557) recommend the lens to a
friend or family member.
About The Tecnis Family of IOLs:
The Tecnis Multifocal Family of 1-Piece IOLs are currently
available in three add powers: +4.0, +3.25 and +2.75. In addition,
the Tecnis Family of IOLs also includes a monofocal 1-Piece IOL and
the Tecnis Toric 1-Piece IOL for astigmatism correction. Each lens
in the Tecnis Family of IOLs features a sophisticated proprietary
design based on validated science and optical principles designed
to offer patients multiple options for post-surgical vision that
best meet their specific visual demands.
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.
Visit Abbott at www.abbott.com and connect with us on Twitter at
@AbbottNews.
1. 2016 Comprehensive Report on the Global IOL
Market, Market Scope(r), LLC.
PP2016CT0582
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SOURCE Abbott