Oraya Therapy Stereotactic Radiotherapy for treatment of wet AMDs now available at Optegra

Oraya^® Therapeutics, Inc. announced today that the Oraya Therapy™ Stereotactic Radiotherapy for the treatment of wet age-related macular degeneration (AMD) is now available at Optegra Manchester Eye Hospital, becoming the second facility in the UK to provide the therapy. The non-invasive Oraya Therapy is intended as a one-time outpatient procedure to reduce the need for routine anti-vascular endothelial growth factor (anti-VEGF) injections into the eye.

“We look to expand access and availability of this important treatment option across Europe, with several additional centers opening in the coming months.”

Globally, wet AMD is the leading cause of vision loss among those over age 65. In the UK, wet AMD affects approximately 260,000 people and it is projected that nearly 40,000 new patients will be affected each year, according to an article published in the British Journal of Ophthalmology. While the efficacy of anti-VEGF compounds has prolonged and saved the eyesight of millions of patients worldwide, it also places a difficult burden on patients, who require costly, uncomfortable, routine injections, as well as an unsustainable burden on the ophthalmic practice and on healthcare systems, which are facing increased patient volume and related expenses.

"Modern anti-VEGF injection treatments have been very successful at preventing loss of vision but patients are often anxious about having repeated eye injections. With Oraya Therapy, it is great to be able to offer patients the possibility of maintaining their vision while reducing their need for injections," said Mr Sajjad Mahmood, MA, MB, BCHIR, FRCOPHTH, consultant ophthalmologist at Optegra Manchester Eye Hospital.

Intended as a one-time therapy, Oraya Therapy offers a unique, non-invasive approach to treating wet AMD. Unlike any other technique, 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 efficacy and safety of the Oraya Therapy has been demonstrated in the INTREPID study, the first sham-controlled, double-masked trial to evaluate the effectiveness and safety for a one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD. 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. An analysis of the best responders in the INTREPID trial shows that anti-VEGF injections were reduced by 55 percent. Best responders also achieved better vision outcomes than similar patients in the sham arm of the study. The number of patients fitting this profile is significant. Published results from the trial are available online in the peer-reviewed journal, Ophthalmology.

"Having participated in trials that scientifically demonstrated the benefits of Oraya Therapy, it's extremely gratifying that this treatment is now available and can benefit more patients with this chronic condition," said Professor Tariq Aslam DM (Oxon), FRCSEd. (Ophth), Ph.D., consultant ophthalmologist at Optegra Manchester Eye Hospital.

Optegra Manchester Eye Hospital is the second location in the United Kingdom to offer the Oraya Therapy. The first centre, Optegra Surrey Eye Hospital in Guildford, began offering the treatment earlier this year. Treatment sites now in development include Basel, Switzerland and new locations within Germany are expected to open in the coming months.

"We are very encouraged by the early response and demand for Oraya Therapy since it first became available in the UK. Hundreds of patients have shown interest in the therapy and many were anxious to have a nearby treatment location in the Manchester area. There was a waiting list for Manchester already in place when the facility began treatments this month," said Oraya President and Chief Executive Officer Jim Taylor. "We look to expand access and availability of this important treatment option across Europe, with several additional centers opening in the coming months."