First European Patient Treated in CABERNET Trial With Novel Treatment for Wet AMD
LEIPZIG, Germany, November 29, 2007 /PRNewswire/ -- NeoVista, Inc. announced today that the first European patient has been treated in the company's pivotal global clinical trial for its novel beta radiation epiretinal therapy for the wet form of age-related macular degeneration (AMD). Wet AMD is the most progressive form of AMD and one of the leading causes of blindness in the industrialized world for patients over 50. Unlike the current standard of care which requires costly monthly eye injections, NeoVista's investigational therapy delivers a one-time dose of radiation providing a less invasive and potentially more cost-effective treatment option.
The procedure was performed as part of NeoVista's CABERNET (CNV Secondary to AMD Treated with BEta RaditioN Epiretinal Therapy) trial, which seeks to enroll a total of 450 patients (300 in the radiation treatment arm) in approximately 40 sites worldwide to evaluate the efficacy and safety of NeoVista's novel radiation therapy. Patients in the study receive a single treatment with NeoVista's targeted radiation in combination with an injection of Lucentis(R) at the time of radiation delivery to maximize immediate effect.
"We're excited to have the opportunity to try this innovative technique with our patients. NeoVista's targeted radiation treatment may provide us the ability to improve vision for the elderly and dramatically change their quality of life by eliminating frequent eye injections," said Christian Foja, MD Leipzig University Eye Hospital, who performed the procedure.
Peter Wiedemann, MD, who oversees the department at Leipzig University Eye Hospital, echoed Dr. Foja's sentiments. "NeoVista is developing a promising new wet AMD treatment that could also be a cost-effective alternative in Europe," said Dr. Wiedemann. "And without having to perform regular, monthly injections that are quite expensive for our patients, this procedure will allow our specialists to treat more patients and bring down the cost associated with ongoing treatment."
Unlike previous forms of radiation therapies for wet AMD, NeoVista's radiation device delivers the peak dose of radiation directly to the lesion minimizing radiation exposure to the surrounding tissue. The minimally invasive procedure utilizes a device similar in size and appearance to a fountain pen, to deliver a highly focused radiation directly to the area of the retina affected by wet AMD. Importantly for patients, the exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epiretinal device is comparable to 15 minutes of sun exposure.
"Ultimately, our goal is to restore vision and quality of life to elderly patients who have been stricken with this debilitating disease by liberating them of the burdens associated with existing wet AMD therapies," said John N. Hendrick, President and CEO of NeoVista. "As our clinical trials continue to show positive results, we are getting closer to achieving that goal and delivering a real solution to physicians and patients."
In addition to Germany, locations of CABERNET study sites include the United Kingdom, Spain, Switzerland, Austria, Israel, Brazil, Mexico, Peru, and the United States. The CABERNET study is intended to support eventual filing for regulatory approval to market the product worldwide.
About Wet AMD
Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, where they leak blood and fluid, causing scar tissue to form and vision to become impaired. With wet AMD vision loss may occur faster and be more noticeable than with dry AMD. The longer the abnormal vessels leak or grow, the more detail vision will be lost. The earlier wet AMD is diagnosed, the better the patients' chance of preserving some or much of their central vision.
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical device company based in Fremont, California. For more information about the company, the clinical trial or this novel wet AMD therapy, please visit the company's Web site at http://www.neovistainc.com.
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Posted: November 2007