Leading ophthalmologists from three European countries have presented patient results following one year after a single treatment with Oraya Therapy for wet age-related macular degeneration (AMD).
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.
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
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 40-74% reduction in the number of injections required to maintain vision, compared to their previous injection needs, with a corresponding significant decrease in macular oedema characterised 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.
“The criteria for identifying the best responder based on the INTREPID study are working quite well,” said Dr Katja Hatz from the Vista Klinik-EyeRAD SWISS Medical Center in Basel, Switzerland.
“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 long-term after Oraya Therapy, which is very encouraging.”
Dr Mahdy Ranjbar from the University Eye Hospital Lübeck, Germany, added: "We saw a very significant 74% 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."
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
Patients newly diagnosed with wet AMD at the 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 the hospital."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,” he 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.”
