Dear Mike: Perhaps you are thinking of this, but it is not NEWS now, came out in February. jdn
FDA Issues Coherent Approvable Letter for Laser Used in Age-Related MacularDegeneration (AMD)
SANTA CLARA, Calif., Feb. 11 /PRNewswire/ -- Coherent, Inc. (Nasdaq: COHR) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the Opal(TM) Photoactivator(TM) and Visudyne(TM) (verteporfin for injection) 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.
The FDA has indicated they will, after final review, approve the Opal Photoactivator concluding Visudyne therapy was most appropriate for patients with the wet form of AMD, characterized by the presence of predominantly classic Subfoveal Choroidal Neovascularization (CNV), the indication sought for in the joint drug / device submission.
The application, filed jointly by Coherent and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI), covers Coherent's new Opal Photoactivator laser developed specifically for use in photodynamic therapy and Verteporfin for injection, the drug which is activated by this special purpose 689nm diode laser. Upon commercialization, CIBA Vision Corporation, the eye care unit of Novartis AG, will market the drug worldwide while Coherent will market the Opal laser worldwide.
In the letter received by QLT and CIBA Vision today the FDA stated that they have reviewed the application and Visudyne therapy is approvable. The FDA recognizes that any remaining deficiencies identified in the letter may have been addressed by recent information provided to the FDA by QLT, but that material is still under review.
The Opal Photoactivator is CE mark certified and Coherent continues to manufacture and ship internationally. Visudyne therapy received regulatory approval in Switzerland on December 16, 1999. Regulatory applications are pending in the European Union, Canada, Norway, Iceland, Australia and New Zealand.
Jim Taylor, President of Coherent Medical Group, stated, "Coherent is proud to have developed the laser technology that activates the Visudyne therapeutic drug and to be a partner in the battle to prevent blindness from AMD. This is part of Coherent's on-going commitment to provide ophthalmologists with a full range of products and technologies, and the first major leg of our focus on providing solutions for AMD."
Jim Taylor added, "Early adoption of the therapy is expected to be high. Clinician awareness, interest and urgency are all exceeding our original assumptions. We are prepared to respond to this increased demand with the support from the Coherent Semiconductor Group, where capacity has been increased to provide the key component, laser diodes, necessary to manufacture the Opal Photoactivator. Our international sales have already significantly exceeded plan in just these market segments and we are at pace to more than meet our total year's projections."
Wet AMD is characterized by the formation of abnormal blood vessels (Choroidal Neovascularization or CNV) that grow across the central part of the retina called the macula.
These vessels leak fluid and eventually cause scar tissue, which destroys central vision. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Verteprofin is injected intravenously into the patient's arm. The drug is then activated by the Opal laser's 689-nanometer light, administered through the patient's pupil in a non-invasive and painless procedure lasting 83 seconds.
Impressive positive results from U.S. clinical trials with Visudyne therapy were published in the October issue of Archives of Ophthalmology, a leading peer review journal. Medical experts estimate that of the 500,000 new patients afflicted with wet AMD every year around the world, 40-60% will progress to a more profound stage of the disease, characterized by predominantly "classic" lesions. It was reported that Visudyne therapy reduces the risk of vision loss during the first year of the study in patients with this type of AMD.
Additional clinical trials are being conducted to determine the effectiveness of Visudyne therapy in patients with an earlier stage of AMD originally excluded from the TAP Investigation as well as patients with a similar but distinct condition of abnormal blood vessels associated with progressive near-sightedness known as pathologic myopia. Results are expected in the second quarter of 2000. |
