Contacts: Sarah Goodwin Kathi Ovnic Holly Korschun

June 18, 1998

FDA ADVISORY PANEL RECOMMENDS APPROVAL FOR LASIK AT EMORY The FDA's Ophthalmic Devices Advisory Panel recommended June 5 the Emory Vision Correction Center in Atlanta for FDA approval for the LASIK (laser in-situ keratomileusis) procedure using a surgical system developed by Emory researchers. This is the first time the federal agency, which typically approves devices or drugs for manufacturers, has granted approval directly to a physician team for a surgical system. The surgical system was developed by cornea specialists George O. Waring III, M.D., R. Doyle Stulting, M.D., Ph.D., and Keith P. Thompson, M.D., who are faculty members of the Emory University School of Medicine Department of Ophthalmology and founders of the Vision Correction Center. "This vote means that Emory has proven through extensive research that its LASIK system is safe and effective for the treatment of nearsightedness up to -15 diopters, which encompasses some 95 percent of all nearsighted patients or approximately 72 million Americans," said Dr. Stulting. "If the FDA follows the panel's recommendations, Emory will be the only center in the country to earn approval to perform LASIK." When performing LASIK, ophthalmologists create a protective flap on the surface of the cornea. A computer-controlled excimer laser gently reshapes the middle layer of the cornea to reduce or eliminate nearsightedness. The surgeon then repositions the flap over the sculpted area to protect it. LASIK is an outpatient procedure that takes about 10 minutes and requires anesthetic eye drops. Most patients return to normal activities the next day with little or no discomfort. "Combining the flap with the laser provides patients with rapid recovery of vision, minimal discomfort, and the ability to fine-tune or adjust vision in the future, advantages not available with other techniques," said Dr. Waring. He served as principal investigator of the clinical research studies conducted to meet the FDA's strict requirements for examining patients following surgery and for analyzing their outcomes. Emory investigators developed a unique system for LASIK surgery that includes a microkeratome that creates the corneal flap, the Summit Technology excimer laser with customized, proprietary software, and a standardized surgical technique. More than 95 percent of patients at Emory report they were satisfied with the procedure, that it improved the quality of their lives, and that they would have LASIK again if given the choice. Dr. Thompson, medical director of the Vision Correction Center, had the procedure himself. "As a microsurgeon, excellent vision is essential," he said. "The quality of my vision following LASIK is far superior to glasses and equals or exceeds contact lenses." Summit Technology of Waltham, Mass., which has worked closely with Emory to conduct research, had previously gained FDA approval of their Apex laser for correcting low to moderate levels of nearsightedness with photorefractive keratectomy (PRK), which does not involve creating a protective flap from the cornea. PRK has more bothersome side effects than LASIK, resulting in slower recovery of vision and more discomfort for patients. The Vision Correction Center continues to expand the capabilities of its LASIK system using new lasers with ablatable masks and scanning slits. New generation laser technology will allow surgeons to treat farsightedness in addition to nearsightedness and astigmatism. The Emory Vision Correction Center has performed more than 5,000 LASIK procedures and is a recognized leader in refractive surgery techniques. The center is located at The Emory Clinic Perimeter, 875 Johnson Ferry Road near the intersection of I-285 and Georgia 400. For more information on LASIK at Emory, call 404/843-EYES or 1-800-SEE-MORE or access the center's World Wide Web site at www.emoryvision.com. - ### -