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New Survey Shows Many U.S. Adults with Impaired Eyesight Worried about Seeing in an Emergency; Vision Care Preparedness Goes Beyond Extra Glasses and Contacts to Permanent Corrective Options via Enhan
December 07, 2005 10:00:00 AM ET
Growing Number of Emergency Workers Choosing LASIK with the IntraLase Method(TM) to Provide Optimum Safety and Service to Others
IntraLase Corp. ILSE today announced survey results concluding many U.S. adults would not feel capable without their glasses or contact lenses during emergency situations. More than one-half (52 percent) of U.S. adults who wear corrective lenses say they would feel worried (40 percent), fearful (22 percent) and/or powerless (18 percent), if they lost or did not have access to their corrective lenses during an emergency. In fact, only one-third (31 percent) of adults who wear corrective lenses say they would feel capable in an emergency if they didn't have or lost their corrective lenses. With recent events focusing attention on disaster readiness, vision care is an important and often overlooked consideration in preparedness.
Nearly one-third (29 percent) of respondents who wear corrective lenses say they are considering LASIK to avoid having problems seeing in an emergency. Interest in having LASIK to avoid problems in an emergency was highest among males ages 35 to 44 (42 percent)(a).
Additional key survey findings include:
- 40 percent of adults who wear corrective lenses reported being worried about losing their glasses or contacts in a disaster.
- Nearly a quarter (23 percent) said they would feel lost if they didn't have their glasses/lenses in an emergency.
- 22 percent say they would feel fearful.
- 18 percent say they would feel powerless.
IntraLase Method of Blade-Free LASIK Offers Safer Procedure
and Better Vision
More than a half-million, blade-free LASIK vision correction procedures
have been performed to date -- a procedure that is only possible with
the IntraLase FS (femtosecond) laser. This ultra-fast laser is proven
to virtually eliminate most severe, sight-threatening LASIK complications,
making the procedure a far safer treatment option for the 34.4 million
nearsighted and 21.1 million farsighted Americans. More IntraLase Method
LASIK patients achieve 20/20 or better vision than with even the most
advanced microkeratome (blade) technology.
"While LASIK has always been a safe and effective procedure, the IntraLase Method offers patients the benefits of LASIK without the blade," said Stephen Updegraff, M.D., medical director of Updegraff Vision in Tampa, Fla. "With its enhanced safety profile and superior visual outcomes, the IntraLase Method is the procedure of choice for patients considering LASIK."
Emergency Workers Choosing LASIK with the IntraLase Method to See Clearly on the Frontline Ophthalmologists also are seeing increasing numbers of police and firefighters having LASIK with the IntraLase Method, as those who respond to emergencies are looking to free themselves of corrective lenses that may hamper their ability to perform their duties.
Ron Reyna, a major in the U.S. Army Reserve and police officer from Jefferstontown, Ky., struggled with wearing thick prescription glasses since the fourth grade. Contact lenses did not work for him, and glasses were difficult to wear on the job. However, two separate incidents made him realize the potential hazard of wearing glasses. Once while pursuing a suspect on foot, Reyna feared losing his lenses and becoming vulnerable to an attack due to his 20/400 eyesight. On another night, he was awoken by his house alarm and, in the hurry to make sure his daughters were safe, he dropped his glasses to the floor.
"Being able to properly see is perhaps one of a police officer's strongest weapons. Having to wear glasses was not just a hassle, but a real detriment to my safety on the job," said Reyna. "I chose LASIK with the IntraLase Method after getting recommendations from my doctor and from others who had had the procedure. Now, whether I'm chasing a suspect or protecting my family, I can concentrate on what I'm doing and not worry about losing my glasses."
Another emergency worker, firefighter David Knecht from Brecksville, Ohio, had become increasingly frustrated with the constant need to adjust his glasses while working, especially when wearing an air mask. Since having his vision corrected with LASIK using the IntraLase Method, Knecht has realized how much time was wasted fumbling for his glasses when getting a late-night call. Whether he is rushing into a smoke-filled building or simply diving into a pool with his family, Knecht no longer worries about his glasses, giving him more freedom both on and off the job.
How LASIK with IntraLase Method Works
The IntraLase FS laser is used in the important first step of the two-step
LASIK procedure, the creation of a corneal flap. The second step involves
reshaping the cornea using an excimer laser. Historically, the first step
was performed using a microkeratome, a hand-held device with an oscillating
metal blade. While LASIK has proven to be a successful and relatively
safe procedure, the majority of complications -- and patient concerns
-- have been associated with use of the microkeratome.
The IntraLase laser eliminates the use of a microkeratome and its blade. With the IntraLase Method, the surgeon precisely controls the first step of LASIK using a computer-controlled laser that delivers rapid pulses of light, a quadrillionth of a second each, to a pre-programmed depth and position within the cornea. Each pulse forms a microscopic bubble. As the IntraLase laser moves back and forth across the eye, the bubbles are connected to form a corneal flap. Just prior to vision correction, the doctor gently lifts the flap to reveal a smooth corneal bed.
Physician-programmed laser specifications include flap diameter, depth, hinge location and width, and side-cut architecture -- factors which can be varied to meet the individual patient's needs. The IntraLase laser also creates a distinctive beveled edge flap, which allows for precise repositioning, alignment and seating after LASIK is completed.
The IntraLase laser prepares an optimal corneal surface below the flap, and in clinical studies this resulted in superior visual outcomes. This benefit was seen when the IntraLase laser is used during either standard LASIK or custom LASIK procedures.
Survey Methodology
Harris Interactive(R) fielded the study on behalf of IntraLase Corp. from
Oct. 7-11, 2005, via its QuickQuery(SM) online omnibus, interviewing a
nationwide sample of 1,367 U.S. adults (18+) who wear corrective lenses.
Data were weighted to be representative of the total U.S. adult population
on the basis of region, age within gender, education, household income,
race/ethnicity, and propensity to be online. In theory, with a probability
sample of this size, one can say with 95 percent certainty that the overall
results have a sampling error of plus or minus 4 percentage points of
what they would be if the entire population of U.S. adults who wear corrective
lenses had been polled with complete accuracy. Sampling error for the
males ages 35-44 sub-sample (97) is plus or minus 16 percentage points.
This online sample is not a probability sample.
(a) Low base. Data should only be used directionally.
About IntraLase Corp.
IntraLase designs, develops, and manufactures an ultra-fast laser, related
software, and disposable devices used to create a corneal flap, the first
step in LASIK surgery for the correction of vision. The company's products
improve the safety, precision, and visual results of LASIK procedures
by providing a computer-controlled laser solution in place of the hand-held
mechanical, metal-bladed microkeratome traditionally used to create corneal
flaps. IntraLase lasers are also used in surgical approaches to the treatment
of diseased corneas. The company's lasers and disposable per procedure
patient interfaces are presently marketed throughout the United States
and 23 other countries. IntraLase has headquarters and manufactures its
products in Irvine. For additional information, visit the company's Web
site: www.intralase.com.
About Harris Interactive(R)
Harris Interactive Inc. (www.harrisinteractive.com), based in Rochester,
N.Y., is the 13th largest and the fastest-growing market research firm
in the world, most widely known for The Harris Poll(R) and for its pioneering
leadership in the online market research industry. Long recognized by
its clients for delivering insights that enable confident business decisions,
the company blends the science of innovative research with the art of
strategic consulting to deliver knowledge that leads to measurable and
enduring value.
Harris Interactive serves clients worldwide through its United States, Europe (www.harrisinteractive.com/europe) and Asia offices, its wholly owned subsidiary Novatris in Paris, France (www.novatris.com), and through an independent global network of affiliate market research companies. EOE M/F/D/V
Contact Information: The Goolsby Group for IntraLase Corp. Liana Miller,
949-595-4320 liana@goolsbygroup.com
© 2005 BusinessWire
Medicare Widens Options for Cataract Surgery - Corrective Replacement Lens Is Allowed for Seniors Able To Pay an Additional Sum
By Rhonda L. Rundle - Wall Street Journal
May 11, 2005
Medicare has changed its rules so that senior citizens who undergo cataract
surgery will be able to opt for a high-tech replacement lens that also
corrects reading vision. The change, announced on Medicare's Web site
yesterday, represents a policy shift that could widen access to other
cutting-edge medical technologies for patients covered by the federal
health insurance plan for the elderly.
The lenses are considered a significant advance in vision correction but hadn't been available to Medicare patients until now. Surgeons who use the implants have been offering them to younger patients willing to spend perhaps $4,500 an eye, but they couldn't offer them to Medicare patients, who constitute the vast majority of people undergoing surgery for cataracts.
Under the old rule, surgeons weren't permitted to charge Medicare patients for the difference between the cost of a conventional cataract surgery, which uses an older type of lens to replace the eye's natural lens, and a similar procedure that uses the new implant. Medicare pays about $2,000 for a standard cataract surgery, including the lens and fees for the facility and the surgeon.
Now, Medicare patients willing to spend an extra $2,500 or so of their own money can get one of the new lenses instead.
"This is an Emancipation Proclamation for Medicare patients," declared Jeffrey Whitman, a Dallas eye surgeon who has implanted about 600 of the new lenses. "We have had to tell Medicare patients that this isn't for you, it's for everybody else. Now we can be nondiscriminatory."
More cataract procedures are performed in the U.S. and world-wide than almost any other type of surgery. A cataract is an age-related cloudiness that occurs in the lens of the eye. The rule change recognizes that the new lenses treat two distinct medical conditions: one that is covered by the Medicare program, cataracts, and one that isn't, presbyopia, the loss of near vision that typically requires people to use reading glasses by the age of 45 or so.
"This is a model we can continue to use and explore when it fits into the category" of a technology upgrade, said Leslie Norwalk, deputy administrator at Medicare, in an interview. "There may be other technologies that come down the road where this approach may make sense -- we will have to wait and see."
Ms. Norwalk said legal issues had slowed the agency's decision to make the cataract-surgery policy change. The agency wanted to allow patients to purchase upgraded lenses, but at the same time wanted to protect beneficiaries from unethical surgeons who might try to bill patients more for conventional cataract surgeries.
The decision is a giant boost for companies that make the new lenses and the surgeons who are implanting them. Dr. Whitman uses the Crystalens, made by Eyeonics Inc., a closely held company in Aliso Viejo, Calif. The Food and Drug Administration recently approved Alcon Inc.'s ReStor lens and the ReZoom lens from Advanced Medical Optics Inc.
The companies were ecstatic about the news. "This is clearly the biggest decision in our small company's life -- it expands our market four or five times," said Andy Corley, chief executive officer of Eyeonics. "We believe this is a win-win for everybody."
"This is a major event for Alcon as well as competitors who are developing and/or marketing intraocular lenses with a presbyopic refractive component," said Peter Bye, an analyst at Citigroup Smith Barney who upgraded his rating on Alcon's stock. The analyst said the ruling increases the market potential for such products to 2.8 million procedures in the U.S. this year, five times what had been expected.
The decision opens the door to cataract surgeons to promote the technology to their Medicare patients. For surgeons, such procedures are significantly more lucrative than conventional cataract surgery. Dr. Whitman says the higher fees reflect the much more time-consuming measurements and postoperative care that such patients need.
Using the new lenses is "more akin to refractive [vision correction] surgery than cataract surgery" because of patient expectations for excellent vision, he said.
Eyeonics has been trying for five years to get the Medicare rule changed, said Mr. Corley. "There were high-level meetings, but they kept delaying and delaying," he said.
The matter received more attention after U.S. Rep. Christopher Cox, a California Republican, stepped in. "It was a Catch-22 situation because Medicare would pay for cataract surgery and a lens, but it wouldn't pay for cataract surgery with a product that was meant to be in lieu of the [standard] lens," Rep. Cox said in an interview.
"Federal policy should not discourage technological advance," he added.
Alcon Launches AcrySof ReSTOR Apodized Diffractive IOL; Revolutionary Apodized Diffractive Technology Provides Highest Level of Freedom from Glasses
April 25, 2005 6:12:00 PM ET
Alcon, Inc., ACL 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 surgeons in Europe and in other countries.
Alcon has begun training U.S. surgeons 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.
Caution Concerning Forward-Looking Statements. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by our forward-looking statements. These statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, competition from other drugs already on the market or competitive drugs that reach the market in the future, challenges inherent in new product manufacturing and marketing, developments in legal cases and government regulation and legislation. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules an regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
Contact Information: Porter Novelli Public Relations Tracy Bone, 312-856-8814 or Alcon, Inc. Investor Relations and Strategic Corporate Communications Doug MacHatton, 800-400-8599 www.alconinc.com
© 2005 BusinessWire
Three-year Crystalens
results show good vision maintained
The three-year clinical results for Crystalens (eyeonics Inc., Aliso Viejo, Calif.) found 92% of patients monocular near visual acuity measured J3 or better (ie able to read 6 point print or better without glasses. 6 point print is equivalent to telephone book and classified ad size text) and more than 90% see 20/25 or better for bilateral uncorrected distance vision, according to the manufacturer. The three-year follow-up was a requirement of the original Food and Drug Administration-approved protocol.
Approved by the FDA in November 2003, Crystalens is designed to provide a continuous range of vision from distance through intermediate to near, in adult patients that undergo cataract surgery and wish to treat their presbyopia. The three-year data found none of the patients showed a loss of accommodation. Crystalens is implanted by more than 300 U.S. surgeons. The three-year data will provide reassurance to physicians and patients that the Crystalens benefits are lasting. For more information go to www.eyeworld.org.
| FOR IMMEDIATE RELEASE Contact: |
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| For consumer/health: Pearson Brown/Smith PR 310-788-0456 |
For medical/technology: Pat Allen/eyeonics, inc. 949-389-1791 |