Coherent Granted Priority Review by FDA for Laser Treatment of Age-Related Macular Degeneration.SANTA CLARA, Calif.--(BW HealthWire)--Aug. 27, 1999-- Coherent, Inc. (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. ) has assigned priority review status to its new joint device/drug application for Visudyne(TM) therapy for the wet form of age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ), indicating that the FDA will act on the application within six months. The application, filed jointly by Coherent and QLT QLT Quadra Logic Technologies QLT Quick Link Text PhotoTherapeutics Inc. (Nasdaq: QLTI), covers Coherent's new OPAL(TM) photoactivator laser, as well as the verteporferin drug which is activated by the special purpose 689nm diode laser device. Visudyne therapy will be marketed globally by CIBA Vision Corporation, the eye care unit of Novartis. The laser and drug are used for the treatment of the wet form AMD, the leading cause of blindness in people over the age of 50 in the western world. Design and development of this laser and new treatment modality underscore the Coherent commitment to "breakthrough" devices. Coherent developed the first commercially available 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. lasers used for photocoagulation photocoagulation /pho·to·co·ag·u·la·tion/ (-ko-ag?u-la´shun) condensation of protein material by the controlled use of an intense beam of light (e.g. in ophthalmology in 1970. The results of the pivotal Phase III trials, known as the TAP (Treatment of AMD with Photodynamic therapy) investigation showed a statistically significant benefit at 12 months to those patients treated with Visudyne therapy compared to those administered a placebo. Results also showed that Visudyne therapy was well tolerated, with the majority of adverse events occurring in similar numbers among the treatment and placebo groups. Jim Taylor, Coherent Medical Group President, said, "We are excited about Coherent's research with the original investigators exploring the field of ocular PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT has culminated in a therapy that will save the sight of many AMD patients." 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. 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 our Web site at http://www.cohr.com for product and financial updates. To receive a full text copy of this press release by fax, please call (877) 329-2647. 5100 Patrick Henry Dr., P. O. Box 54980, 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. 95056-0980 . Telephone (408) 764-4000 |
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