Development stage company NeoVista (Fremont, California) in late November reported the first patient treated in the company's pivotal trial for its beta radiation epiretinal therapy for the wet form of age-related macular degeneration (AMD), a leading cause of blindness for those over 50.

The company differentiates the technology from current treatments requiring costly monthly eye injections, saying its epiretinal therapy delivers a one-time dose of radiation providing a less invasive and potentially more cost-effective treatment.

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. The procedure was performed as part of NeoVista's CNV Secondary to AMD Treated with BEta RaditioN Epiretinal Therapy (CABERNET) trial, enrolling 450 patients (300 in the radiation treatment arm) in about 40 sites worldwide. Patients in the study receive a single treatment with NeoVista's radiation in combination with an injection of Lucentis at the time of radiation delivery.

"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, of Leipzig University Eye Hospital, who performed the procedure.

Unlike previous radiation therapies for wet AMD, NeoVista's device delivers the peak dose of radiation directly to the lesion, minimizing radiation exposure to the surrounding tissue. The company says the effective dose to the entire body from the device is comparable to 15 minutes of sun exposure.

John Hendrick, president/CEO of NeoVista, said, "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 UK, Spain, Switzerland, Austria, Israel, Brazil, Mexico, Peru, and the U.S. The CABERNET study is intended to support regulatory approval for worldwide marketing.

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. The longer the abnormal vessels leak or grow, the more detail vision will be lost.