Three-year safety data from INTREPID study of Oraya Therapy™ for wet age-related macular degeneration results announced

Sep 15 2014

Oraya Therapeutics Inc. announced that full results of three-year safety follow-up data from the INTREPID study of Oraya Therapy™ for wet age-related macular degeneration (AMD) further demonstrated a favorable safety profile and also showed that there was no significant difference in vision outcomes in patients treated with Oraya Therapy compared with those receiving anti-vascular endothelial growth factor (anti-VEGF) injections alone. Oraya Therapy uses low-energy, highly targeted X-rays to treat Wet AMD and is intended as a one-time procedure with the potential to maintain vision while reducing the required number of anti-VEGF injections into the eye.

The three year safety evaluation consisted of detailed image analysis looking for the presence of microvascular changes related to radiotherapy. Although small localized changes were identified by the reading center in a quarter of the patients, they did not significantly affect vision.

Commenting on the INTREPID study, Professor Ian Rennie, Consultant Ophthalmologist and Professor of Ophthalmology and Orthoptics and International Expert in Treatments of Ocular Cancers at Sheffield Teaching Hospitals NHS Foundation Trust said;

Of the cases I reviewed that were identified by the study expert panel as having microvascular changes attributable to radiation, most cases were so subtle that I would consider them clinically insignificant.

The INTREPID study was the first to evaluate the safety and efficacy of Oraya Therapy in conjunction with as-needed anti-VEGF injections for patients with Wet AMD, and is the only sham-controlled double-masked trial to assess stereotactic radiotherapy for Wet AMD. The study met primary and secondary endpoints and showed that Oraya Therapy significantly reduces the need for anti-VEGF injections while maintaining vision in the presence of a favorable safety profile. A total of 21 sites in five European countries participated in the trial. Two-year results showed that a broadly inclusive cohort of previously treated Wet AMD patients continued to receive the benefits of a 25 percent mean reduction in anti-VEGF injections over two years. Additionally, the targeted patient population maintained an impressive 45 percent mean reduction in injections through two-year visit, with stable vision.

The three-year safety results were presented today at a EURETINA seminar where physicians also discussed their clinical experiences treating patients with Oraya Therapy.

These impressive results coupled with increasing interest from physicians and patients, have led the Heart of England NHS Foundation Trust to become the second NHS centre to install the technology. Patient treatment at the Trust is due to commence in October 2014. The Heart of England closely follows the Royal Hallamshire Trust in Sheffield, which began offering this innovative therapy in July of this year. The commercial use of Oraya Therapy has been rapidly expanding in Europe, with the treatment now available in a total of eight centres across the United Kingdom, Germany and Switzerland. It is covered by insurance in all three countries.

“As we conclude this ground-breaking three-year study of Oraya Therapy, results are showing that treatment can and is maintaining patients’ vision while significantly enhancing their quality of life,” said Oraya President and CEO Jim Taylor.

This result, coupled with the rapid expansion of the availability of Oraya in the UK, and indeed across Europe, makes this a very exciting time for the company.

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.