Oraya Therapeutics, Inc. announced today that it is significantly expanding its presence in Europe, with Oraya Therapy being offered for the first time at a National Health Service hospital in the United Kingdom and at four prestigious university hospitals in Germany. Oraya Therapy is intended as a one-time, non-invasive treatment for wet Age-related Macular Degeneration, with the potential to maintain or enhance vision while significantly reducing the required number of anti-vascular endothelial growth factor (anti-VEGF) injections into the eye.
The recognition of Oraya Therapy as an important option in the wet AMD treatment regimen is illustrated by both its rapid adoption and by insurance coverage of the therapy in the U.K., Germany and Switzerland. Royal Hallamshire Hospital, part of the Sheffield Teaching Hospitals NHS Foundation Trust and the first National Health Service hospital in the U.K to offer Oraya Therapy, began treating patients in April. Several additional NHS hospitals are expected to offer Oraya Therapy by the end of the year.
In Germany, the four centers offering Oraya Therapy are University Hospital Essen, University Hospital Schleswig-Holstein Campus Luebeck, University Hospital Freiburg, and the Medical Care Centre of the University Hospital of Cologne. These will soon be joined by additional locations that are working toward adding Oraya Therapy before the end of 2014. Dieter Staubitzer, the Chairman of Bundesverband Auge, one of the largest chronic eye disease advocacy groups in Germany, stated in an announcement to its membership, “There is a need for new, more flexible methods of treatment. Both the doctors and patients are looking for a new way to treat wet AMD. We have great hopes for this new treatment.”
“The adoption of Oraya Therapy at these five sites in the first half of 2014 represents a significant advance for Oraya, and we anticipate the second half of the year will meet or exceed this level of growth,” said Oraya Therapeutics President and CEO Jim Taylor. “The reception to Oraya Therapy is very positive. An increasing number of patients and physicians are inquiring about this clinically proven and commercially tested therapeutic option. Importantly, these highly respected and centrally located treatment centers offer patients, their families and their physicians a valuable and much-needed option for treating Wet AMD.” The five new centers join the VistaKlinik in Basel Switzerland, where treatments were first initiated in 2013.
Anti-VEGF injections transformed the care of wet AMD patients when the treatment first became commercially available, yet the limitations of this approach are well known. Anti-VEGF therapy places a significant burden on patients and providers alike, primarily due to the frequency of injections required. Consequently, many patients are unable to maintain the level of injection therapy needed to provide optimum vision results. Wet AMD is the primary cause of blindness in developed countries. This challenge is becoming greater every year with the rapid growth of the aging population throughout Europe due to the “Baby Boom” generation.
The efficacy and safety of the Oraya Therapy have been demonstrated in the INTREPID study, the first sham-controlled, double-masked trial to evaluate the effectiveness and safety of a one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD in non-naïve patients. The study met its primary endpoint by reducing the frequency of anti-VEGF injections by 32 percent for the treated patients compared with the control group.
Two-year results of the study also showed that the targeted patient population – those with significant macular fluid and lesions that fit within the X-ray beam - maintained a 45 percent mean reduction in injections through the two-year visit, with stable vision. The broadly inclusive cohort of previously treated wet AMD patients continued to receive the benefit of a 25 percent mean reduction in anti-VEGF injections over two years. The majority of existing and new wet AMD patients meet the target patient criteria, indicating that the benefits of Oraya Therapy are broadly applicable to the wet AMD population.
Oraya Therapy employs a low-voltage X-Ray source with advanced robotics, a laser-guided positioning system, and a patented methodology for eye stabilization and tracking. The procedure is delivered in an outpatient setting, averaging 20 minutes and requiring no post-treatment recovery period before resuming normal activity.
The IRay® Radiotherapy System is a CE marked medical device. In the U.S., the IRay System is an investigational device and is not available for sale. For more information, please visit www.orayainc.com.