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NEWSFDA ApprovesBausch & Lomb Technolas® 217z Zyoptix™ System For Personalized Vision Correction,The World’s Leading System for Custom Laser Eye Surgery,For Use in United States
FOR RELEASE FRIDAY, OCTOBER 10, 2003
ROCHESTER, N.Y. – Bausch & Lomb (NYSE:BOL) has received approval from the U.S. Food and Drug Administration for its patented, advanced laser eye surgery system − the Bausch & Lomb Technolas® 217z Zyoptix™ System for Personalized Vision Correction − now making the world’s leading technology for custom laser eye surgery available in the United States.
Since 2001, surgeons have used the Zyoptix system, available throughout Europe, Asia, Latin America and Canada, to successfully perform approximately 100,000 personalized LASIK procedures.
The Zyoptix system has the widest treatment range of any custom laser eye system available in the United States. Zyoptix LASIK surgery can correct up to –7.00 diopters of nearsightedness (myopia) with up to –3.00 diopters of astigmatism and “manifest refraction spherical equivalent” equal to or less than −7.50D. MRSE is a measurement that describes the total refractive error of the eye.
Designed to provide truly personalized laser vision correction, the Zyoptix platform combines an upgraded Bausch & Lomb Technolas 217 excimer laser with the advanced diagnostics of the Zyoptix Diagnostic Workstation unit and Zylink™ treatment software.
“The Zyoptix technology produced superb results based on all measurements including visual acuity and quality, patient satisfaction and on my own experience,” said Stephen G. Slade, M.D., of Houston, medical director of the FDA clinical trials. "Availability of Zyoptix system vision correction should give patients the confidence to seek surgery and surgeons the advanced technology to deliver the best possible outcomes."
The Zyoptix system allows the surgeon to create a precise map of both the inside and the outside surfaces each patient’s cornea, and using wavefront technology, gives the surgeon the ability to measure the unique imperfections within each patient’s optical system. These imperfections include higher-order aberrations, detectable in low-light conditions like driving at night, and contribute to visual disturbances such as reduced contrast sensitivity, glare or halos. Higher-order aberrations are correctable only through wavefront-guided customized laser vision correction like that offered by the Zyoptix system.
“With the Zyoptix system we found that about 40-percent of patients reported having better night driving vision than they did before surgery, which, in my experience, is an unprecedented result,” said Scott M. MacRae, M.D., a surgeon who participated in the clinical trials, and professor of Ophthalmology at the University of Rochester Medical Center and professor of Visual Science at the Center for Visual Science at the University of Rochester in Rochester, N.Y.
The U.S. clinical study was the basis for the Company’s FDA submission. It was conducted at three centers in the United States: Houston (with Dr. Slade), Rochester, N.Y. (with Dr. MacRae) and Overland Park, a suburb of Kansas City, Kan. (with Dr. Dan Durrie). Clinical trial results are based on a cohort of 340 eyes with a combination of myopia and astigmatism. Highlights include:
· 91.5% of patients had unaided 20/20 vision or better (Uncorrected Visual Acuity); · 70.3% of patients had unaided 20/16 vision.
· 99.0% of subjects reported that they were satisfied with the results; · 99.7% indicated improvement in quality of vision, of which more than 40% reported improvement in night vision while driving. · No patients reported dissatisfaction with their outcomes.
# # # Notes to reporters and editors:
Interviews For interviews with Dr. Scott MacRae in Rochester, call his office at 585.341.7816.
For interviews with Dr. Stephen Slade in Houston, call his office at 713.626.5544 or his mobile telephone at 713.922.8064.
Multimedia Available: RADIO ANR: An audio news release is available today on Audioline, AP Radio and Westwood One Radio. For more information call Tim Doyle at 414-321-6210.
TV VNR: The video news release about the Zyoptix system will be fed today, October 10, from 1:00p.m. - 1:30 p.m. ET on Telstar 6, Transponder 15 (C-Band), downlink frequency: 4000 (V,Audio: 6.2 & 6.8 MHz). For hard copy requests, contact Harbour Media Relations at 518-583-9982 ext. 10. For technical information, today only call 917-992-0920.
The VNR also is available on www.newstream.com
Contacts: News Media: Margaret Graham 585.338.5469
Investor Relations: Daniel L. Ritz 585.338.5802 Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Celebrating its 150th anniversary in 2003, the Company is headquartered in Rochester, New York. Bausch & Lomb’s 2002 revenues were $1.8 billion; it employs approximately 11,500 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb.
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