FDA Panel Recommends Approval of Coherent Laser; Coherent Moves to Final Stage of Approval Process.SANTA CLARA, Calif.--(BW HealthWire)--Nov. 18, 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. ) Ophthalmic Drugs Subcommittee recommended approval of the Opal(TM) Photoactivator and Visudyne 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. ). This recommendation is an important step towards the goal of making Visudyne therapy available to the many thousands of patients who lose vision every year. Both the panel and the FDA concluded that Visudyne therapy was most appropriate for patients with predominantly classic subfoveal choroidal cho·roi·dal adj. Of or relating to the choroid. choroidal pertaining to or emanating from the choroid. choroidal hypoplasia neovascularization (CNV CNV Choroidal Neovascularization (eye disorder) CNV Christelijk Nationaal Vakverbond CNV Copy Number Variation CNV Conveyor CNV Chief of Navy CNV Continuous Normal Voltage CNV Crypto Net Variable CNV Could Not Verify ), the indication proposed by co-developers CIBA Vision, the eye care unit of Novartis AG, and QLT QLT Quadra Logic Technologies QLT Quick Link Text PhotoTherapeutics Inc. (Nasdaq:QLTI). The application, filed jointly by Coherent and QLT PhotoTherapeutics Inc., covers Coherent's new Opal(TM) Photoactivator laser developed specifically for use in photodynamic therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. and Visudyne, the drug which is activated by this special purpose 689nm diode laser. Visudyne will be marketed globally by CIBA Vision Corporation. Jim Taylor, President of Coherent Medical Group, stated "It is exciting to be a partner in the battle to prevent blindness from macular degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision. . This new laser is one step in our strategy to provide a full range of products and technologies to target the various forms of age related macular degeneration. Coherent is prepared to supply and support the large number of lasers we anticipate ophthalmologists will need upon FDA approval." Typically, the subcommittee, a panel of expert consultants to the FDA, would be asked to vote on whether or not they recommend a product be approved. In the case of Visudyne, the FDA did not ask the panel to formally vote on approvability, but sought guidance in efficacy and confirmation of safety and product labeling. At the conclusion of the hearing, the panel members voluntarily expressed their view that the therapy should be approved. The panel's conclusions will be taken into consideration by the FDA as it completes its review of the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Visudyne therapy, which was submitted on August 16, 1999. The FDA is expected to make a final decision regarding the approval of the Visudyne application on or before February 2, 2000. Regulatory applications are also pending in the European Union, Canada, Switzerland, Norway, Iceland, Australia and New Zealand. Extensive positive results from Phase III clinical trials involving Visudyne therapy to treat the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world were published in the October issue of a leading peer-review medical journal, Archives of Ophthalmology This article is about the journal published by the American Medical Association. For other journals and uses, see Ophthalmology (disambiguation). The Archives of Ophthalmology . It was reported that Visudyne therapy reduces the risk of vision loss, compared to placebo, during the first year of the study in patients with the wet form of AMD. The comprehensive analysis reveals that Visudyne therapy shows beneficial effects in the total study population. Additionally, the data shows that a subgroup of patients whose lesions were characterized by a specific, more aggressive, disease pattern experienced a large, clinically relevant benefit. "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. Founded in 1966, Coherent, Inc. is a Standard & Poor's SmallCap 600 company and a world leader in the design and manufacture of lasers and 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. |
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