Autonomous Completes U.S. Phase III Surgeries.ORLANDO, Fla.--(BW HealthWire)--April 28, 1997--Autonomous Technologies Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ATCI ATCI Albany Transcomm International ) today announced completion of the minimum patient entry sample size it believes meets the requirements of the clinical study guidelines provided 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. to establish the safety and efficacy of its T-PRK (R) System. Completion of the clinical studies for the correction of low to moderate myopia myopia: see nearsightedness. with 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. for the company's U.S. Phase III surgeries occurred earlier than had previously been expected. Preparation for its PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy application has begun with expected submission later this year. The company also announced very preliminary results of these multicenter Phase III trials as presented at the annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS ASCRS American Society of Cataract and Refractive Surgery ASCRS American Society of Colon and Rectal Surgeons ) in Boston. The company has entered 504 eyes of 445 subjects from six clinical sites into the Phase III study for up to 10 diopters of mean spherical equivalent myopia including up to 6 diopters of astigmatism. The data from a single site low myopia study show extremely strong 20/20 results at greater than 90%, due to a low average correction of 3.0 Diopters, for the small group (N=41) reaching six months. The Phase III broader range, multicenter study from four sites show 70% of patients reaching 20/20 by 3 months (N=132) however, 3 months is too early to be indicative of true outcome as visual acuity improvements are expected up to 6 and 12 months. The company continues to have no patients losing more than two lines of BCVA BCVA Best Corrected Visual Acuity BCVA British Cattle Veterinary Association (Gloucestershire, UK) at six months. Speed of recovery showed 96% of 207 patients achieved 20/40 by 1 month. Study accountability of the patients eligible at 1, 3 and 6 month intervals, respectively, shows 99.5%, 97.5%, and 98.0% of patients, had received post-operative exams. Randy Frey chief Executive Officer of Autonomous Technologies Corp., said "Completion of Phase III patient entry minimum requirements is the most critical milestone for the company thus far. We can now start the clock on the follow-up data to support our PMA application. We are very encouraged by the preliminary data presented at ASCRS and believe it to be right in line with our expectations for the expanded range of correction. Our T-PRK(R) technology continues to demonstrate superior results." Autonomous Technologies Corp. (ATCI) is engaged in the design and development of next generation excimer laser instruments for laser refractive surgery. ATCI's T-PRK(R) (Tracker-assisted Photorefractive Keratectomy) instrument combines high speed, laser radar eye tracking (LADARVision (R)) with precisely controlled narrow beam shaping technology. CONTACT: Autonomous Technologies Roslyn Palmiere Investor Relations 407/282-1262 or Lippert/Heilshorn & Associates, Inc. Evan D. Smith, CFA/Keith L.Lippert 212/838-3777 |
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