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THE FDA APPROVES FIRST ACCOMODATING INTRAOCULAR LENS
Crystalens Implanted in Cataract Surgery Restores Up-Close,
Far-Away and Everything-In-Between-Vision to Patients
Aliso Viejo, CA, November 14, 2003 – Eyeonics, inc.TM , the developer of a new class of visual enhancement systems, today announced that it has received FDA approval to market the Crystalens, the first and only accommodating intraocular lens that allows patients to focus automatically and seamlessly at all distances.
“Crystalens is a revolutionary new breakthrough in vision enhancement,” said J. Andy Corley, chairman and CEO of eyeonics. “It is an intraocular lens replacement for cataracts that accommodates like the eye’s natural lens, allowing for seamless focusing up close, far away and at all distances in between, giving patients their best possible vision.” The ability to provide patients with clear vision at all distances is a significant technological breakthrough in the competitive field of intraocular lens technology. “Unlike standard IOLs, the Crystalens restores vision at all distances and in most cases eliminates the need for glasses and contacts for everyday tasks. Giving people the ability to focus at all distances is a singular advantage over all current cataract procedures,” Corley stated.
The Crystalens is the result of more than 14 years of research and development by J. Stuart Cumming, MD, F.A.C.S., FRCOphth, Chief Scientific Officer of eyeonics, inc. and developer of the Crystalens technology. Early in his research, Cumming noted that the ciliary muscle in the eye did not stop functioning in older patients. Therefore he created a lens that works by moving in a backwards and forwards motion along the axis of the eye in response to pressure changes in the front and back of the eye that result from relaxation and contraction of the ciliary muscle. This muscle inside the eye is responsible for focusing the eye in younger patients. As a result, patients experience the vision they had when they were younger, for most without the hassles of corrective lenses. In contrast, standard intraocular lenses restore only distance vision – therefore patients may still require glasses or contacts to see up close and all points in between. “Most people don’t realize how much vision occurs at arm’s length and at in between distances,” said Cumming. “In between vision means you can sit at your computer, read a magazine or engage in a hobby, even use a golf scorecard, in most cases without corrective lenses,” he said. Market potential for the Crystalens is significant with 20.5 million Americans aged 40 and over suffering from cataracts (National Institutes of Health). “During clinical trials, we greatly reduced or eliminated the need for glasses in patients when both eyes were implanted – the impact on someone’s life is dramatic when they get back to the best vision possible enjoying the activities that used to be a challenge such as reading, driving, sports, hobbies or even reading the instructions on a bottle of medicine,” Cumming stated.
U.S. Clinical Trials
During clinical trials, 497 eyes were implanted with the Crystalens over
a two-year period.
“This lens brings us one step closer to the eyes we were born with,” said Paul Koch, MD, a leading ophthalmic surgeon in Rhode Island and one of the clinical investigators. “I’ve never seen such positive response from my patients, in most cases they are returning to the hobbies and activities they love without distance or magnifying glasses or other corrective lenses. Crystalens helps the patients to look their best and to experience a freedom and empowerment that will allow them to feel their best.” For more information about finding a physician or to learn more about the lens please visit Crystalens at www.crystalens.com.
About eyeonics, inc.
Eyeonics, inc., a venture-backed medical device company headquartered
in Aliso Viejo, California, was founded in 1998 by J. Andy Corley, Chairman
and CEO and J. Stuart Cumming, MD, Chief Scientific Officer and Crystalens
developer and cataract surgeon for over 25 years. eyeonics is committed
to developing a new class of visual enhancement systems that will enable
patients to see up close, far away and all distances in between. The Crystalens
Accommodating Intraocular lens is the company’s first U.S. product.
eyeonics has also received 25 patents with 51 pending. eyeonics currently
has 40 U.S. employees and maintains a manufacturing facility in Rancho
Cucamunga, California and an international sales office in Rome, Italy.
Worldwide more than 6,000 lenses have been implanted to date. For more
information about eyeonics, inc. and the technology go to www.crystalens.com.
New Prospective Study Shows Patients Achieve Better Vision when INTRALASE FS Laser Performs First Step of Custom Laser Vision Correction
Results to be presented at American Academy of Ophthalmology Anaheim, California - November 15-18, 2003
(Irvine, Calif., Nov. 4, 2003) - IntraLase Corp. is pleased to announce the results of a new controlled, prospective randomized study that demonstrates significantly better patient outcomes when the IntraLase® femtosecond laser replaces the traditional microkeratome in performing the first step of custom laser vision correction surgery.
The controlled study, conducted by Daniel S. Durrie, MD of Overland Park, Kansas, evaluated 51 patients, 102 eyes, postoperatively at one day, one week and one month. One eye received the traditional microkeratome approach with Bausch & Lomb's Hansatome® and the fellow eye the IntraLase FS laser. All cases were completed with Alcon's LADARVision® CustomCornea® customized laser vision correction treatment in both eyes. Dr. Durrie will also present study findings on dry eye and patient preference for their vision in the IntraLase-treated eye at 1 month post-op. Dr. Durrie's study will be presented on Friday, November 14, at the ISRS/AAO Subspecialty Day at 8:54 a.m. The presentation will be repeated at the IntraLase Education Theater, Booth 3677, on Sunday, November 16, at 2 p.m. The femtosecond laser will also be featured in a live refractive surgery broadcast on Saturday morning, November 15, provided by Alcon, Inc. and co-sponsored by IntraLase Corp.
INTRALASE is a registered trademark of IntraLase Corp. LADARWave and CustomCornea are registered trademarks of Alcon, Inc., Hansatome is a registered trademark of Bausch & Lomb.
Trudy Larkins
Director, Marketing & Communications
IntraLase Corp.
Ph: 877 393 2020 x 192
INTRALASE CORP. REPORTS SHARP RISE IN Q2 SPECIALTY OPHTHALMIC LASER SALES, SIGNS FIRST INTERNATIONAL DISTRIBUTION AGREEMENTS
Ophthalmic Laser Company Accelerating Market Share Due to Better Patient Outcomes, High Surgeon Satisfaction
(Irvine, Calif., July 31, 2003) — IntraLase Corp., a privately-held ophthalmic specialty laser company in Irvine, California, announced the placement of 22 lasers in the second quarter of 2003. This milestone marks the Company’s strongest quarter since the commercialization of its INTRALASE ® FS laser in early 2002. The Company’s proprietary femtosecond laser, and accompanying IntraLASIK ® software, replaces the handheld microkeratome device traditionally used to create the corneal flap as the first step in LASIK vision correction surgery.
“IntraLase Corp. is rapidly gaining market share among refractive surgeons,” reports Robert J. Palmisano, IntraLase President and CEO at the recent EDF Ventures Annual Meeting. “This outstanding performance represents a 144% increase over Q2 2002, bringing our total placements to 64 at quarter end. Based on excellent clinical results reported by surgeons employing the INTRALASE FS laser, this new surgical approach is providing a high degree of surgeon confidence and satisfaction. Surgeons consider the laser an essential technology for optimal patient care noting exceptional precision and improved visual results. By significantly improving the accuracy of flap creation, the INTRALASE FS laser may even contribute to the predictability and improved outcomes of the new customized vision correction technologies.”
In more than 69,000 surgeries using the IntraLase product, no severe complications have been reported in U.S. clinical experience. This is a dramatic improvement over traditional microkeratome procedures which have associated vision threatening complications in 1% to 3% of procedures.
MarketScope, LLC, an industry research organization, estimates that the INTRALASE FS laser was used in 7% of all U.S. vision correction surgeries in Q2 2003; up from 5% market share that was reported in Q1.
“As preference for the INTRALASE FS Laser continues to grow clinically, we are also seeing the impact of the technology on surgeon practices and revenue enhancement,” notes Mr. Palmisano. “It is literally changing the standard of care in many practices across the vision correction industry.” Typically, surgeons charge a premium of $250 - $500 more per eye for the procedure with the INTRALASE FS laser due to the higher acquisition cost of the new technology.
Refractive surgeon Herman Sloane, M.D., echoes the achievement of IntraLase Corp as he recently proclaimed Q2 as his highest volume quarter since the events of 9/11. Dr. Sloane, a private practice surgeon in Chicago, attributes this uptick directly to the conversion to IntraLase technology in his practice. “Since acquiring the INTRALASE FS laser a year ago, more patients are electing to go ahead with the surgery. Response from our patients is extremely positive before and after surgery.”
Perry S. Binder, M.D. of Gordon Binder Vision Institute in San Diego adds, “In choosing the IntraLase approach for their vision correction surgery, patients readily understand and appreciate the potential safety and reduction of risk factors. The contribution of the INTRALASE FS laser to surgeon control and precision in creating the corneal flap produces markedly predictable and accurate flaps, and exceptional patient peace of mind. This laser, combined with wavefront guided vision correction developments, provides the optimal platform for truly customized vision correction surgery.”
Separately, Mr. Palmisano announced IntraLase Corp. has entered into its first international distribution agreements, marking the introduction of the INTRALASE FS laser to the global market. First international placements have been established in Japan, and shipments to Korea are anticipated for September 2003. “New technologies such as the INTRALASE FS laser re-kindle patient interest in vision correction surgery and enable surgeons to continually improve on the quality of patient care,” remarked Mr. Palmisano. “IntraLase Corp. is very pleased with such rapid clinical adoption and will strive to make its technology widely available this year throughout the U.S” A European launch is envisioned for early next year.
For more information on IntraLase Corp. and femtosecond technology,
visit www.intralase.com.
###
IntraLase and IntraLASIK are registered trademarks of IntraLase Corp.,
Irvine, California.
Contact: Trudy Larkins, Dir. of Marketing & Comms.
877-393-2020, ext. 192; tlarkins@intralase.com
FDA Approves New, First-of-Its-Kind LASIK Technology
October 23, 2002 08:06:00 AM ET
HUNENBERG, Switzerland, Oct. 23 /PRNewswire-FirstCall/ -- Alcon, Inc. ACL has received approval from the U.S. Food & Drug Administration (FDA) for its advanced laser eye surgery system, called the LADARVision(R) System, for customized wavefront-guided laser eye surgery in the treatment of nearsightedness.
With this newly approved system, made up of the LADARVision 4000(R) excimer laser system and the new LADARWave(TM) diagnostic device, surgeons can, for the first time, measure and treat visual disorders that previously could not be detected. This highly customized approach creates a new laser eye surgery procedure, called LADARVision(R) CustomCornea(R), that improves both visual acuity, which is measured against standard numerical outcomes such as 20/20, and the overall quality of vision, such as increased visual crispness and clarity. Visual acuity of 20/20, considered by most as the standard for vision, has been traditionally measured by a letter chart, which does not provide for detection of many of the disorders that may affect vision.
Several types of imperfections, referred to as lower- and higher-order aberrations, exist within the eye and can affect both a person's visual acuity and the quality of vision. To date, only lower-order aberrations, which include nearsightedness, farsightedness and astigmatism, could be measured and treated. However, lower-order aberrations do not account for all potential vision disorders. Higher-order aberrations can also have a significant impact on a person's quality of vision, and cannot be corrected with glasses, contacts or conventional LASIK. According to experts in the field of ophthalmology, higher-order aberrations are linked to visual disturbances such as glare and halos that may cause night vision problems and are sometimes associated with conventional LASIK surgery.
The LADARVision(R) System is the first-and-only FDA approved eye surgery system that can measure both lower- and higher-order aberrations, and can actually be used to treat each patient's unique pattern of lower- and higher-order visual errors.
A New Standard for Success
"LADARVision(R) CustomCornea(R) is a tremendous breakthrough in laser eye surgery that raises the bar in this field," says Stephen Brint, MD, clinical associate professor of ophthalmology, Tulane University School of Medicine, who, as the first surgeon in the U.S. to perform LASIK surgery, is also the medical director of the FDA clinical trials.
"Since the 1800s, we've used the same type of eye exam, the letter chart, to measure visual problems, which only provided a partial picture of a patient's visual errors," Dr. Brint explains. "With this approval, we're no longer simply dealing with just nearsightedness, farsightedness and astigmatism. Rather, the LADARWave(TM) measurement device allows us to look at the entire optical system from front to back, measure all of the factors that can affect the quality of a person's vision, and then use the information obtained by this first-of-its-kind technology to customize the very distinct treatment needs of each patient."
In LADARVision CustomCornea clinical trials, nearly 90 percent of patients who underwent the new laser eye surgery procedure achieved 20/20 vision, but even more importantly, they reported a quality of vision superior to that achieved with conventional LASIK.
"Sometimes patients complain about vision quality problems, such as not being able to see in dim or low light. This is referred to as poor contrast sensitivity," explains Roger Steinert, MD, associate clinical professor of ophthalmology, Harvard Medical School. "Prior to the advent of wavefront measurements, there wasn't anything we could do to measure or treat higher-order aberrations. With this technology breakthrough, we can now measure these disorders, show the patient what's going on in their eye, link that information to the laser, and actually correct higher-order aberrations that diminish contrast sensitivity. Wavefront technology enables the surgeon to improve overall vision quality better than in the past."
How It Works
In order to create the customized map unique to each patient's eye, the LADARWave device transmits a safe ray of light into the patient's eye. It is important that these measurements are taken when the eye is fully dilated, so that all the visual distortions that may interfere with vision during various parts of the day can be measured. The light is then reflected back off the retina, out through the pupil, and into the device, where the reflected wave of light is received and arranged into a unique pattern that captures the patient's lower- and higher-order aberrations. All of these visual irregularities are then displayed as a three-dimensional map, referred to as a wavefront map. This information is then electronically transferred to the LADARVision(R) 4000 excimer laser, and computer-matched to the eye's position, enabling the surgeon to customize the LASIK procedure to each patient's unique visual requirements. This is the only FDA-approved system that actually uses wavefront data to guide laser treatment.
The LADARVision 4000 excimer laser, previously approved by the FDA in 1998, was originally designed to work seamlessly with the LADARWave(TM) device. Incorporating tracker technology developed by NASA to track satellites, the LADARVision 4000 locks-on to the eye during surgery, allowing the wavefront map to be precisely aligned and maintained throughout the procedure ensuring accurate placement of the laser beam to reshape the cornea. Without this sophisticated tracking system, the laser treatment could be misaligned and result in inaccurate corneal reshaping and an inability to treat higher-order aberrations.
"LADARVision is a technologically superior excimer laser system that we anticipated would propel LASIK surgery into the future," says Bill Barton, VP and General Manager, Alcon Surgical Division. "With the FDA approval of our CustomCornea(R) application, the future is here and we are tremendously pleased to introduce this exciting new technology to our customers and their patients."
Clinical Trials
The LADARVision CustomCornea FDA clinical trials began in 1999 and were conducted at five sites in the U.S. and Canada. In these trials, more than 500 eyes were treated for nearsightedness, with 98 percent achieving 20/25 vision or better, 88 percent realizing 20/20 vision or better, and 63 percent achieving 20/16 vision or better. In addition, in these trials LADARVision was proven to address higher-order aberrations, provide an increase in contrast sensitivity and demonstrate an improvement in vision quality over conventional laser vision correction. Clinical trials of this new system are ongoing to determine the effectiveness of its use for nearsightedness with astigmatism, farsightedness with and without astigmatism, and the treatment of eyes with other special visual disorders, such as pre-existing night vision problems and post-LASIK complications.
Alcon, Inc. is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for more than 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.
Caution Concerning Forward-Looking Statements. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, relating principally to our ability to successfully market and sell the system for wavefront-guided laser eye surgery. 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, the following: general economic conditions in the United States and internationally; technological advances attained by our competitors; challenges inherent in new product marketing; 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 and 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.
For information, contact: Doug MacHatton (Alcon Investor Relations), 800-400-8599, or Mary Dulle (Alcon Public Relations), 817-551-8058.
Alcon Leads the Industry With PMA Filing for Custom LASIK Surgery
FORT WORTH, Texas, May 2 /PRNewswire-FirstCall/ -- Alcon, Inc. ACL announced today that the U.S. Food and Drug Administration (FDA) has accepted its custom wavefront-guided laser eye surgery Pre-Market Approval Application (PMA). As this is the first filing accepted by FDA, it means Alcon is leading the industry in regulatory review of custom laser surgery. The acceptance of this filing marks a significant milestone in the FDA review process.
Alcon was the first company to initiate FDA clinical trials for custom LASIK surgery using a wavefront measurement device and an excimer laser. LADARWave(R) surgical system, Alcon's wavefront measurement device, measures the optical aberrations of the entire eye. These measurements are used by Alcon's LADARVision(R) 4000 excimer laser to uniquely reshape the cornea. By design, the LADARWave and LADARVision 4000 work together to perform the precision ablations required in custom laser surgery while tracking eye movements at 4,000 times per second.
"We are pleased to be first in the industry to be so far along in custom wavefront-guided LASIK technology," said Bill Barton, VP and General Manager, Surgical Division. "Custom LASIK surgery has the potential to improve visual acuity and enhance overall vision quality as compared to today's conventional LASIK surgery. Alcon is excited about the prospect to provide this technology to its customers and to their patients."
Alcon, Inc. is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for more than 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. The LADARVision 4000 and other refractive products are commercially available in the United States and International markets.
Caution Concerning Forward-Looking Statements. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, relating principally to the acceptance by the FDA of our PMA and the expected benefits of custom wavefront-guided laser eye surgery. 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, the following: we may never gain FDA approval of the PMA or approval of the PMA may take longer than we expect; general economic conditions in the United States and internationally; technological advances attained by our competitors; challenges inherent in new product marketing; 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 and 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.
For information, contact:
Doug MacHatton (Investor Relations)
800-400-8599
News media inquiries: Mary Dulle (Corporate Communications)
817-551-8058
www.alconinc.com