Visx Receives FDA Approval
to Treat Myopic Astigmatism
Millions of Americans with Myopic Astigmatism
Are Candidates for Laser Vision Correction
VISX, Incorporated has announced that the U.S. Food and Drug Administration (FDA) has approved the VISX Star Excimer Laser System for use in the treatment of low-to-moderate nearsightedness with astigmatism, offering millions of Americans with astigmatism a new alternative to eyeglasses, contact lenses and astigmatic keratotomy. The approval allows eyecare practitioners to treat adults 21 years of age and older with up to -6.0 D spherical myopia (spectacle plane) with -0.75 D to -4.0 D astigmatism (spectacle plane).
"This is a landmark day not only for VISX and our customers, but for the millions of Americans with astigmatism who are unhappy with contact lenses or glasses," Mark Logan, VISX chairman and chief executive officer said. "Approval to treat astigmatism will lead to happier patients and should help grow the overall number of procedures."
Data from Bruce Jackson, MD, of the University of Ottawa Eye Institute and Ottawa General Hospital, and a VISX clinical investigator, show that 98 percent of eyes treated with up to 6.0 D of spherical myopia and concomitant astigmatism of up to 4.0 D attained 20/40 vision without correction.
"The patients are extremely satisfied with their correction," Dr. Jackson said. "In fact, our data showed an 81 percent reduction in the magnitude of astigmatism." "The advanced technology of the VISX System is a key factor in the successful application of laser vision correction for the treatment of astigmatism," clinical investigator James Salz, MD, of Cedars-Sinai Medical Center said.
The VISX STAR Excimer Laser System features micro-processor-controlled integration modules that shape the beam and homogenize its energy to produce a consistent, uniform photoablation with every pulse. The resulting smooth ablation of the VISX System helps ensure that patients will attain excellent uncorrected vision within a very short recovery time.
VISX has been successfully treating astigmatism internationally since 1990. All VISX systems sold in the United States are capable of correcting astigmatism with a simple software change via a keycard. No additional hardware or disposables are required.
"The procedure is exactly the same for the patient," Julian Stevens, MD, consultant ophthalmic surgeon at Moorfields Eye Hospital in London said. "The ablation depth is no deeper when you treat astigmatism as compared to when you are just treating simple myopia." Of 530 eyes treated at Moorfields, less than one percent of eyes lost two lines or more of best corrected visual acuity according to Dr. Stevens.
"The strong safety and efficacy profile suggests that laser vision correction for astigmatism may become the preferred method of treatment over toric contact lenses and glasses," Raymond Stein, MD, consultant ophthalmologist with Beacon Institute in Toronto said. "It is now our common practice to employ laser vision correction to correct all of our astigmatic patients, even those who present with very low levels of cylinder."
Since 1991, Dr. Stein has performed more than 5,000 laser vision correction procedures using VISX technology. With U.S. approval, the company plans to initiate a training program to certify current users for the treatment of astigmatism and begin distributing VisionKeyx cards for astigmatism immediately.
Based on international experience, approximately two thirds of the patients undergoing laser vision correction procedures have been treated for some measure of astigmatism. With this in mind, VISX believes U.S. approval of astigmatism could increase the total number of laser vision correction procedures performed domestically.
Updated September 21, 1998