KeraVision to Develop Intacs for Possible Treatment of Keratoconus Corneal Thinning Disease; Clinical Trials Scheduled for Five European Medical Sites.Business Editors and Medical Writers FREMONT, Calif.--(BUSINESS WIRE)--Jan. 18, 2000 KeraVision, Inc. (Nasdaq: KERA), developer of Intacs(TM) corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). segments for the treatment of nearsightedness nearsightedness or myopia, defect of vision in which far objects appear blurred but near objects are seen clearly. Because the eyeball is too long or the refractive power of the eye's lens is too strong, the image is focused in front of the , has begun clinical trials in Europe using the company's patented Intacs technology as a possible treatment for keratoconus, a progressive thinning-of-the-cornea disorder. Keratoconus affects an estimated 272,000 Americans and approximately 370,000 people in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , or about one person in 1,000, according to some experts' estimates. Intacs for keratoconus are based on the same patented technology used in KeraVision's initial product, Intacs for mild nearsightedness, or myopia myopia: see nearsightedness. , which the Food and Drug Administration approved in 1999 for sale in the U.S. KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said, "KeraVision has been encouraged by the initial clinical results of European surgeons, led by Dr. Joseph Colin in France, who have been using Intacs in their own independent keratoconus studies. It appears that Intacs may be useful in treating not only keratoconus but other vision disorders caused by thinning of the cornea cornea: see eye. ." Keratoconus results in thinning and bulging of the cornea that can lead to blindness. Current treatments include contact lenses, nutritional therapies and corneal transplants. "Keratoconus is a disorder that so far has eluded an effective treatment," said Joseph Colin, MD, professor and chairman of ophthalmology at Brest University, Brest, France. Dr. Colin, who in 1997 performed the world's first Intacs treatment on a keratoconus patient and has reported his clinical data at numerous medical conferences since then, added, "By building up the cornea and restoring a more natural curvature, Intacs may help prolong the ability of these patients to see with glasses and contacts and possibly delay or eliminate their need for corneal transplants. Results with Intacs are very preliminary but appear promising." Arthur B. Epstein, OD, FAAO FAAO, n.pr See Fellow of the American Academy of Osteopathy. , who is a leading authority on keratoconus and director of contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience. services at North Shore University Hospital - New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the School of Medicine, said, "With the increasing interest in vision correction procedures and advances in diagnostic technologies, we are finding that the incidence of corneal thinning disorders including keratoconus may be more than double what was previously thought. This is why KeraVision's leading-edge work is so important." Intacs consist of clear, ultra-thin, precision-engineered polymers that are placed in the periphery of the cornea (the dome-shaped "window" at the front of the eye) during a brief outpatient procedure. By adding material to the eye, Intacs are designed to remove irregularities in the cornea's curvature and change the way light rays reach the retina, thereby correcting vision. The keratoconus trials are expected to involve a total of 40 patients at five medical sites in Brest, France; Manchester, England; Munich, Germany; and two sites in Milan, Italy. Subject to clinical results, KeraVision could apply as early as this year for European approval to sell Intacs for the treatment of keratononus throughout the European Union. Plans for possible U.S. clinical trials have not been determined. Other clinical trials involving Intacs include hyperopia hyperopia (hī'pərō`pēə): see farsightedness. (farsightedness) studies in Europe and Phase III myopia (nearsightedness) studies in the U.S. for a potentially wider range of correction than originally approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . KeraVision already received FDA approval to sell Intacs for mild myopia, which affects an estimated 22 million Americans. KeraVision, founded in 1986, is the developer of Intacs for the treatment of myopia, which was named one of "The Year's Top 10 Medical Advances" by CNN CNN or Cable News Network Subsidiary company of Turner Broadcasting Systems. It was created by Ted Turner in 1980 to present 24-hour live news broadcasts, using satellites to transmit reports from news bureaus around the world. and Health magazine. Intacs, the first FDA-approved non-laser option for surgically treating mild myopia, or nearsightedness, are a safe and effective alternative to eyeglasses eyeglasses or spectacles, instrument or device for aiding and correcting defective sight. Eyeglasses usually consist of a pair of lenses mounted in a frame to hold them in position before the eyes. , contact lenses and vision correction surgeries that permanently alter the eye's central optical zone. The company's patented technology platform is also being developed for the possible treatment of other common vision problems including mild hyperopia (farsightedness) and astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. . Except for the historical information, the matters discussed in this news release are forward-looking statements. Actual results may differ materially due to a variety of factors, including market acceptance of KeraVision Intacs, complications relating to the product or the surgical procedure, competitive products and technologies, and other risk factors contained in Form 10-Q for the quarter ended Sept. 30, 1999, and under the heading "Risk Factors" in the registration statement on Form S-3 dated Aug. 12, 1999, as well as in other SEC filings. Note to Editors: Intacs are a registered trademark or trademark of KeraVision, Inc. in the U.S. and foreign countries |
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