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Autonomous Technologies receives FDA approval to expand U.S. FDA trials to include astigmatism and higher myopia.


ORLANDO, Fla.--(BUSINESS WIRE)--December 18, 1996--Autonomous Technologies, Corporation (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 that the Food and Drug Administration (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.
) has approved the inclusion of higher myopia and astigmatism patients as part of its existing T-PRK(R) Phase III clinical trials.

The Company reported that the FDA approved the expansion of its ongoing clinical trials to include subjects with higher degrees (up to -10 Diopters) of myopia and up to -6 Diopters of astigmatism, for a maximum spherical equivalent correction of -10 Diopters. The higher myopia/astigmatism investigation may be conducted in up to 7 sites on 500 patients.

Autonomous entered Phase III low myopia U.S. FDA clinical trials in October 1996, and presented clinical results from its T-PRK(R) System for laser vision correction at the October 1996 Annual Meeting of the American Academy of Ophthalmology The American Academy of Ophthalmology (AAO) is a medical association of ophthalmologists–medical doctors (MDs) specializing in eye care and surgery).

The group is based in San Francisco, California.
 in Chicago. The T-PRK(R) System is bringing patients with low to moderate myopia to 20/20 uncorrected visual acuity in over 80% of the cases after six months. In addition, 0% of patients have shown a loss of two lines or more of best corrected visual acuity at six months, which is the principle safety criteria for the FDA.

According to Randy Frey, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Autonomous, "The FDA's approval to expand our T-PRK(R) FDA trials to include broader patient entry criteria within our existing clinical trial schedule is a significant milestone for the company and offers us a strategic advantage. The 500 patients who are already required to establish safety and effectiveness, can now offer Autonomous the flexibility to stratify the data for the broader indication. Consequently, without extending the anticipated time line for completion of our clinical trials, we will be in a stronger competitive position upon commercialization of T-PRK(R) in the U.S."

Autonomous Technologies Corporation (ATCI) is engaged in the design and development of next generation excimer laser instruments for laser vision correction. ATCI's T-PRK(R) (Tracker-assisted Photorefractive Keratectomy) instrument combines high speed, laser radar eye tracking (LADAR LADAR Laser Radar
LADAR Laser Detection & Ranging
 Vision(R) with precisely controlled narrow beam shaping technology.

Statements in this Press Release which express belief, anticipation or expectations, as well as other statements which are not historical fact, are forward looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 and involve risks and uncertainties that could cause actual results or performance of the company to differ materially from the results or performance described herein.

CONTACT: Roslyn Palmiere

Investor Relations

Autonomous Technologies

(407) 282-1262

or

Keith Lippert/Evan Smith, CFA (Computer Fraud and Abuse Act of 1986) Signed into law in 1986, the CFA was a significant step forward in criminalizing unauthorized access to computer systems and networks. The Act applies to "federal interest computers" that include any system used by the U.S.  

Lippert Heilshorn & Associates, Inc.

(212) 838-3777
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 18, 1996
Words:426
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