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Coherent, Inc. Announces Pending 510K Clearance of its Laser for Treatment of Open Angle Glaucoma.


SANTA CLARA, Calif.--(BW HealthWire)--Sept. 23, 1999--

Coherent, Inc. (Santa Clara, CA) (Nasdaq: COHR COHR Congolese Observatory of Human Rights ) announced today that the U.S. 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.
) is reviewing its regulatory submission which seeks marketing clearance for the Selecta 7000(TM) laser, designed to perform Selective Laser Trabeculotherapy (SLT SLT Salut (French)
SLT Sri Lanka Telecom
SLT Senior Leadership Team
SLT Something Like That
SLT Selective Laser Trabeculoplasty
SLT South Lake Tahoe (California)
SLT Single Line Telephone
). SLT is an exciting new therapy for the treatment of open angle glaucoma, the leading cause of preventable blindness in Americans over the age of 40.

The specific indication requested is for the treatment of open angle glaucoma in patients who are uncontrolled on maximally tolerated medical therapy and/or in whom argon argon (är`gŏn) [Gr.,=inert], gaseous chemical element; symbol Ar; at. no. 18; at. wt. 39.948; m.p. −189.2°C;; b.p. −185.7°C;; density 1.784 grams per liter at STP; valence 0.  laser trabeculoplasty Laser Trabeculoplasty
In this procedure the laser attempts to open the normal drainage channels of the eye so fluid can drain more effectively.

Mentioned in: Glaucoma
 (ALT) has failed. The only alternative previously available to these patients was conventional invasive surgery Invasive surgery
A form of surgery that involves making an incision in the patient's body and inserting instruments or other medical devices into it.

Mentioned in: Laser Surgery
 called trabeculectomy, a procedure that many patients resist. Market estimates indicate as many as 300,000 Americans may be waiting for an alternative to trabeculectomy.

Glaucoma is a progressive degenerative disease in which the optic nerve optic nerve: see vision.  is slowly destroyed. If left unchecked 100% of glaucoma cases result in total blindness. The only accepted treatment for open angle glaucoma is to lower intraocular pressure intraocular pressure
n.
The pressure of the intraocular fluid within the eye.


intraocular pressure (in´tr
.

SLT lowers intraocular pressure by using short pulses of low energy laser light to illuminate specific cells in the eye's trabecular meshwork Trabecular meshwork
A sponge-like tissue located near the cornea and iris that functions to drain the aqueous humor from the eye into the blood.

Mentioned in: Glaucoma
 -- resulting in increased fluid outflow. SLT is much less traumatic to the eye than the current laser technique called ALT. ALT does irreparable damage to the eye, and can only be performed twice on each eye during the patient's lifetime. SLT works at a cellular level, preserves the tissue structure and appears to be fully repeatable. Clinical data indicates SLT can lower intraocular pressure in patients that have already exhausted their ALT treatment options.

The predominant method for treating open angle glaucoma is with ocular drugs in the form of eye drops. Many of the most popular glaucoma drugs have a series of side effects Side effects

Effects of a proposed project on other parts of the firm.
 ranging from pulmonary distress, cardiac arrhythmia, depression fainting and impotence. These drug-related effects occur when the medication passes through the eye and enters the patient's blood stream or central nervous system. The most vulnerable patients are asthmatics, diabetics and those with anaphylactic anaphylactic /ana·phy·lac·tic/ (an?ah-fi-lak´tik) pertaining to anaphylaxis.
anaphylactic (an´
 allergies and cardiovascular disease. With only transient, relatively minor side effects, SLT gives doctors the ability to deliver vision-saving therapy without these side effects. Drug therapy is often less effective due to patient compliance since glaucoma medications often require multiple doses per day at regular intervals. SLT does not require patient compliance.

SLT is being performed today in many international markets using Coherent's Selecta 7000. Domestically, Coherent has received exclusive license to commercialize SLT and market the relevant laser technology.

There may also be an additional economic benefit. According to "Prevent Blindness America" and the National Eye Health Program it is estimated that the U.S. government spends over $1.5 billion annually in terms of social security benefits, lost income, tax revenues and health care expenditures in its fight against glaucoma. SLT could significantly lower the glaucoma patients' need for both costly drug therapy and office visits.

Coherent also announced that on Wednesday, September 29, 1999, Coherent will present in Washington, D.C. to Senator Connie Mack (R-FL), Chairperson of the Joint Economic Committee (JEC) at a Research and Development fair. The fair will showcase some of the latest breakthroughs in the biotechnology and biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 community and demonstrate how these breakthroughs are changing and improving our standard of living. The R&D fair is being held in conjunction with the Summit the committee is holding that day, "Putting a Human Face on Biotechnology," to explore the effects of biotechnology on our economy, our standard of living and our everyday lives.

Coherent Medical is a world leader in the development of laser products and services for ophthalmic, aesthetic, and surgical applications.

"Safe Harbor" Statement Under 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  

The statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to currency adjustments, contract cancellations, manufacturing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company's products and services and other risks identified in the Company's SEC filings. Actual results, events and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are encouraged to refer to the risk disclosures described in the Company's reports on Forms 10-K, 10-Q and 8K, as applicable.

Coherent, Inc., of Santa Clara, California Santa Clara, California (IPA: /ˌsæntəˈklærə/) , founded in 1777 and incorporated in 1852, is a city in Santa Clara County, in the U.S. state of California. , is a Standard & Poor's SmallCap 600 company and a world leader in design, manufacture and marketing of lasers and laser systems for medical, scientific, and commercial applications. Please direct any questions to Peter Schuman, Director of Investor Relations at 408/764-4174. For more information about Coherent, visit Coherent's Web site at http://www.cohr.com. To receive a full text copy of this press release by fax, please call 877/329-2647.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Sep 23, 1999
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