March 21, 2005, Alcon, Inc., announced the launch of the AcrySof(R)
ReSTOR(R) Intraocular Lens (IOL) at a press conference during the
American Society of Cataract and Refractive Surgery (ASCRS) and
the American Society of Ophthalmic Administrators (ASOA) Symposium
in Washington.
Approved on March 21, 2005 by the U. S. Food and Drug Administration
(FDA), AcrySof(R) ReSTOR(R) is the first and only IOL that uses
apodized diffractive technology to provide cataract patients with
and without presbyopia a quality range of vision. In clinical trials,
80 percent of patients reported "never" wearing reading glasses
or bifocals following bilateral cataract surgery. The vast majority
of patients who undergo cataract surgery today receive traditional
IOLs, which typically require patients to use reading glasses or
bifocals for near vision following surgery.
The AcrySof(R) ReSTOR(R) lens is a foldable IOL that represents
breakthrough technology because of its unique, patented optic design,
which allows patients to experience the highest level of freedom
from glasses ever achieved in IOL clinical trials. The AcrySof(R)
ReSTOR(R) IOL uses a combination of three complementary technologies:
apodization, diffraction and refraction, to allow patients to experience
a full range of high-quality vision without the need for reading
glasses or bifocals. This range of vision without glasses is achieved
through the optical properties of the IOL. The benefit for patients
is a high level of spectacle freedom. Alcon has patented the application
of apodization technology to an IOL, making the AcrySof(R) ReSTOR(R)
lens the first and only apodized diffractive IOL.
"In almost 40 years, the three most important developments in
ophthalmic surgery have been phacoemulsification, the IOL and the
AcrySof(R) ReSTOR(R) IOL," said Richard Mackool, MD, clinical investigator
of the AcrySof(R) ReSTOR(R) IOL and Director of The Mackool Eye
Institute and Laser Center and Senior Attending Surgeon at The New
York Eye and Ear Infirmary. "The AcrySof(R) ReSTOR(R) IOL is not
only an innovative way to replace the human lens, but it most accurately
restores the vision achieved with a normally functioning natural
lens. It is the last piece of the puzzle that leads to better vision
without glasses for the vast majority of patients."
AcrySof(R) ReSTOR(R) IOL does not rely on the ciliary muscle,
which weakens with age, to enable the eye to quickly change focus
to see objects at near, intermediate and far distances. This allows
80 percent of cataract patients with and without presbyopia (age-related
vision loss) the ability to see clearly without the aid of glasses
or bifocals.
"Once I received the AcrySof(R) ReSTOR(R) IOL, I was free of
glasses," said Susan Byrne, New York resident and clinical trial
patient. "It gave me the vision I had when I was in my 20's. Being
able to see clearly without glasses is amazing and has truly changed
my life."
Clinical trials were conducted in the United States and Europe
to establish the safety and effectiveness of the AcrySof(R) ReSTOR(R)
IOL. A total of 566 people received the AcrySof(R) ReSTOR(R) lens
in the clinical trials. The mean patient age in the studies was
69. Since its introduction outside the U.S. in 2003, more than 11,000
AcrySof(R) ReSTOR(R) IOLs have been implanted in patients by more
then 900 doctors in Europe and in other countries.
Alcon has begun training U.S. doctors on the new lens and shipments
will begin in early-May. Many factors should be taken into consideration
when choosing an IOL, so patients should consult with their ophthalmologist
to determine if the AcrySof(R) ReSTOR(R) IOL is right for them.
Due to current insurance and Medicare coverage, this IOL may not
be available to all patients.
About AcrySof(R) ReSTOR(R) IOL
The AcrySof(R) ReSTOR(R) IOL features a unique, proprietary apodized
diffractive optic design that provides the ability to focus images
from various distances correctly on the retina without mechanical
movement of the lens. This optic design results in an increased
range of quality vision that delivers a high level of spectacle
freedom. Apodization improves image quality by optimizing light
energy delivered to the retina by distributing the appropriate amounts
of light to near and distant focal points, regardless of lighting
situation. This new IOL is particularly well-suited for patients
who wish to reduce their dependency on reading glasses and bifocals
once their cataractous lens is removed.
The AcrySof(R) ReSTOR(R) IOL is based on the AcrySof(R) design
and material platform. AcrySof lenses are the fastest growing and
most frequently implanted lenses in the world, with more than 21
million implants since its introduction in the early 1990s.
About Cataracts
A cataract is a "clouding" of the eye's natural lens, which results
in blurred or defocused vision. According to a recent article published
in the Archives of Ophthalmology, more than 20 million adults in
the U.S. have developed cataracts making it the number one cause
of poor vision in the United States. While not all cataracts require
surgery, nearly three million cataract procedures are performed
annually in the U.S. Cataracts cannot be prevented and are the leading
cause of treatable blindness worldwide. According to the National
Eye Institute, the number of Americans with cataracts is expected
to increase to over 30 million people by the year 2020.
About Alcon
Alcon, Inc. is the world's leading eye care company with sales
exceeding $3.9 billion in 2004. Global sales of its intraocular
lenses, primarily the AcrySof(R) family of lenses, totaled more
than $580 million in 2004. Alcon, which has been dedicated to the
ophthalmic industry for over 50 years, develops, manufactures and
markets pharmaceuticals, surgical equipment and devices, contact
lens solutions and other vision care products that treat diseases,
disorders and other conditions of the eye. For more information
on Alcon, Inc., visit the company's Web site at www.alconinc.com.
