Oraya Therapeutics, Inc. announced that results of its INTREPID study evaluating the safety and efficacy of Oraya Therapy Stereotactic Radiotherapy for the treatment of Wet Age-Related Macular Degeneration (AMD) have now been published, online in the leading peer-reviewed journal Ophthalmology. The study met primary endpoints, showing that a single dose of Oraya Therapy significantly reduces the need for anti-VEGF injections for patients with Wet AMD, with a favorable safety profile one year after administration.
Intended as a one-time radiation therapy, Oraya Therapy offers a unique non-invasive approach to treating Wet AMD, the primary cause of blindness in the industrialized world. Unlike any other radiation technique, Oraya Therapy employs a low-voltage X-Ray source with advanced robotics, 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 results of the INTREPID study reported to date are encouraging for clinicians and individuals with Wet AMD. The prospect of maintaining vision while needing fewer eye injections will appeal to any patient receiving anti-VEGF therapy, and for certain subsets in the trial there is the added advantage of an improved visual outcome,” said Timothy L. Jackson, PhD, FRCOphth, King's College Hospital, London, lead investigator for the trial and lead author of the paper.
The INTREPID study was the first trial to evaluate the effectiveness and safety of the Oraya Therapy in conjunction with as-needed anti-VEGF injections. It is the only sham-controlled double-masked trial to assess stereotactic radiotherapy for wet AMD. A total of 21 sites in five European countries participated in the trial with a total enrollment of 230 patients.
“The results of the INTREPID trial illustrate the broad benefits of the Oraya Therapy for patients, clinicans and health care providers,“ stated Oraya Therapeutics CEO Jim Taylor. “It is rare for a new therapy to demonstrate improved patient outcomes while simultaneously offering the potential to significantly reduce treatment burden and costs. The validation of the safety and efficacy of Oraya Therapy in a rigourous clinical trial and the publication of the INTREPID results in the prestigious journal Opthalmology are not only rewarding but mark a significant step forward in the advancement of this important therapy.“
Results of the INTPREPID study showed that patients who had previously been treated with anti-VEGF for up to three years experienced a 32 percent reduction of injections and substantially drier retinas with Oraya Therapy compared with the control group, and 25 percent of Oraya Therapy patients needed no further injections. Wet AMD patients most suited to the therapy showed a reduction in anti-VEGF injections of more than 54 percent, while also achieving better vision outcomes than patients in the sham arm of the study. In the treated population, 33 percent of the patients required no additional injections for the one-year trial duration, compared to none of the sham patients experiencing that outcome.
The IRay Radiotherapy System is a CE marked medical device and the Oraya Therapy is available to patients in the United Kingdom at the Optegra Surrey Eye Hospital in Guildford. It will be available in Basel, Switzerland starting in May 2013 at the Vista Eye Klinik. In the USA The IRay Radiotherapy System is an investigational device and is not available for sale.