Oraya Therapeutics Inc. announced today that leading ophthalmologists from three European countries presented patient results following one year after a single treatment with Oraya Therapy for wet age-related macular degeneration (AMD), during a symposium at the European Society of Retina Specialists' 15th Congress in Nice, France. The results show that Oraya Therapy is effective in maintaining vision with reduced injections for patients at different stages of their disease—from chronic patients in discontinuous treatment to treatment-naive patients with new diagnosis—and following different treatment pathways.
Chronic patients treated with Oraya Therapy maintained vision with less fluid in the macula and fewer injections compared to same-patient history. These patients experienced a significant 40 percent to 74 percent reduction in the number of injections required to maintain vision compared to their previous injection needs, with a corresponding significant decrease in macular oedema characterized by a decrease in central macular thickness. Patients were offered Oraya Therapy if they met the responder profile from the INTREPID sham-controlled masked study of Oraya Therapy adjunctive to anti-VEGF for treating wet AMD.
Dr. Katja Hatz, from the Vista Klinik-EyeRAD SWISS Medical Center in Basel, Switzerland, remarked:
The criteria for identifying the best responder based on the INTREPID study are working quite well. During the one-year follow-up, we see a drying of the retina and therefore are able to extend the patients’ anti-VEGF treatment intervals over the longterm after Oraya Therapy, which is very encouraging.”
The experience of Dr. Mahdy Ranjbar from the University Eye Hospital Lübeck, Germany is similar.
We saw a very significant 74 percent reduction in the number of injections with stable vision for the first patients to reach one-year, and the patients at six months are showing a similar positive pattern.”
Patients newly diagnosed with wet AMD at Royal Hallamshire Hospital in Sheffield, UK that had Oraya Therapy during their initial anti-VEGF loading phase experienced significantly better vision than patients entering the wet AMD service prior to the introduction of the therapy. “Our Oraya patients were able to achieve clinical-trial level vision gains, maintained through month 12, while receiving fewer injections than the historical control group,” said Christopher Brand, consultant ophthalmic surgeon at Royal Hallamshire Hospital in the U.K. “Equivalent patients not receiving Oraya Therapy did not experience any vision gain over the same period. This looks like a real positive for the patient and our service.”
Oraya Therapy Stereotactic Radiotherapy delivers highly targeted, low-energy X-rays to the diseased area of the eye and is intended as a one-time outpatient procedure. The rationale for the use of Oraya Therapy adjunctive to anti-VEGF therapy was reviewed by Professor Frank Zimmerman from the University of Basel, Switzerland. “The dose of 16 Gy delivered in one session with high precision—as is done with the IRay® radiotherapy system—is in the optimal range to act synergistically with existing anti-VEGF treatments to counter proliferation of the neovascular lesion,” Zimmerman said. “The precision with which the X-ray is directed at a very small volume of tissue is a new aspect to this treatment, resulting in a strong biological effect with a high degree of safety.”
Presenting ophthalmologists and radiation specialists included Mr. Timothy Jackson, consultant ophthalmic surgeon at Kings College Hospital in the U.K.; Prof. Frank Zimmerman, a professor at the Radiation oncology Department at the University Hospital Basel in Switzerland and cooperating radiation oncologist with the Vista Klinik-EyeRAD SWISS Medical Center in Basel, Switzerland; Dr. Mahdy Ranjbar, with the department of ophthalmology at the University of Luebeck in Germany; Dr. Katia Hatz, from the Vista Klinik-EyeRAD SWISS Medical Center in Basel, Switzerland; and Mr. Christopher Brand, consultant ophthalmic surgeon at Royal Hallamshire Hospital in the U.K.
"We are extremely pleased with the clinical outcomes presented at EURETINA, which offer further evidence that Oraya Therapy can benefit so many wet AMD patients," said Oraya President and CEO Jim Taylor. "We continue to see enthusiasm for Oraya Therapy from a diverse patient population, with many travelling from multiple destinations globally to the European sites where Oraya Therapy is offered, and often paying out of pocket for treatments. Some patients are even returning for treatment in their second eye after successful treatment with Oraya Therapy in the first eye. We look forward to expanding the number of clinics offering Oraya Therapy in the UK and Germany in the coming months."
More than 500 patients have been treated with Oraya Therapy in three European countries, including Switzerland, Germany and the United Kingdom.
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.
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