Laser Eye Surgery, PRK, LASIK, LTK
FDA Approves Sunrise Technologies
Hyperion LTK System
Fremont, CA, (June 30, 2000) *Sunrise Technologies International, Inc. (NASDAQ/NMS: SNRS) today announced that the U.S. Food and Drug Administration has approved the Company's HYPERION LTK (Laser Thermal Keratoplasty) System.
The laser time for the SUNRISE LTK Procedure is three seconds per eye and involves no cutting or removal of corneal eye tissue. The HYPERION LTK System gently heats eye tissue outside the center of the cornea, thereby causing it to steepen and reduce hyperopia (farsightedness).
"The HYPERION LTK System, the first refractive laser procedure designed specifically for farsightedness, is a breakthrough technology that represents the latest available alternative for the estimated 60 million(1) farsighted individuals over the age of 40 within the United States," said C. Russell Trenary III, President and CEO of Sunrise.
Farsightedness is the most common refractive error of the American population, with about 77 million total farsighted individuals. An independent research study known as The Baltimore Eye Study(1) (conducted by investigators from Johns Hopkins University and supported by grants from the National Institutes of Health), revealed that the number of Americans over age 40 with hyperopia is nearly twice as large as those with myopia. In fact, the Study projected that by the Year 2000, there would be 118 million Americans over the age of 40 -- and about 60 million of them (or 52 percent) would be hyperopic. About 62 percent, or approximately 40 million, of these hyperopes were expected to be low to moderately farsighted in the range of +0.75 to +2.50 diopters, the initial approved indication for use of the SUNRISE LTK Procedure.
Approval of the premarket approval application for the HYPERION LTK Laser System is for the temporary reduction of hyperopia in patients with +0.75 to +2.50 diopters of MRSE with less than or equal to +/- 0.75 diopters of astigmatism, who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.50D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.
Ophthalmologists Sandra C. Belmont, M.D., F.A.C.S., and Brian S. Boxer Wachler, M.D., who are both clinical investigators for Sunrise Technologies, look forward to offering the SUNRISE LTK Procedure as a new option for their farsighted patients.
"I believe that the SUNRISE LTK Procedure will become the procedure of choice for farsightedness because of its excellent safety profile, effectiveness, low learning curve for physicians, and ease of treatment for the patient. As is the case with most doctors, I understand that no single technology will treat all refractive conditions. We needed a good, safe, quick procedure for farsighted patients, and now we have it," said Dr. Belmont, who is Director of the Laser Vision Correction Center and Corneal Service at New York Weill Cornell Medical Center of New York Presbyterian Hospital in New York City, where she is an Associate Professor of Clinical Ophthalmology.
"The SUNRISE LTK Procedure is the first technology that brings refractive surgery to a comparable safety level of soft contact lenses. LTK breaks through the 'fear factor' for patients considering laser eye surgery," said Dr. Boxer Wachler, Director of the UCLA Laser Refractive Center and Assistant Professor of Ophthalmology of the Jules Stein Eye Institute at the UCLA Department of Ophthalmology in Los Angeles.
How Sunrise LTK Procedure Works
The Sunrise LTK Procedure uses laser energy to gently reshape the cornea without touching the eye. It differs from currently available procedures because no scalpel incisions or laser ablations are used to cut or remove corneal tissue, and it differs from intracorneal ring and intraocular lens procedures because no objects are inserted into the eye.
Instead, a holmium:YAG laser utilizing a patented process for shrinking collagen applies two concentric rings of eight simultaneous spots of laser energy to the periphery of the cornea (not the visually important center of the cornea that you see through) to gently heat the corneal collagen and steepen its shape, thereby improving its refractive (focusing) power. Because no tissue is cut and the eye is not touched by any instruments, the possibility of intra-operative complications, postoperative infections, or risk of healing irregularity that may affect vision is minimized.
In U.S. clinical trials of the SUNRISE LTK Procedure, patients generally had improved vision immediately after the procedure, and most people were able to return to work and resume their regular activities the day after treatment. Topical anesthetic eye drops were used prior to the procedure and patient complaints of post-operative pain or discomfort were usually minimal, lasting about 24 hours or less. When required, over-the-counter analgesics were prescribed, and were typically discontinued within one to two days.
Sunrise Technologies International, Inc., is a Fremont company that produces and markets high technology products revolutionizing treatment methods in eye care. The Company develops Holmium laser-based systems which utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic conditions. These Systems incorporate a non-contact simultaneous application for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging), and over-correction resulting from PRK and LASIK treatments for myopia. The presbyopia and over-correction indications are currently under clinical investigation in the U.S. The Sunrise LTK Procedure is currently in use in Europe, South Africa, Canada, Central America and South America.
Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including market potential, regulatory clearances, business growth and other risks listed from time to time in the Company's Securities and Exchange Commission (SEC) filings. These forward-looking statements represent the Company's judgment, as of the date of this release, and the Company disclaims any intent or obligation to update these forward-looking statements.
(1) The Baltimore Eye Study, an independent study conducted by investigators from Johns Hopkins University and supported by grants from the National Institutes of Health, published in Investigative Ophthalmology & Visual Science, February 1997.
Created July 5, 2000