Oraya Therapy — A New Option
Oraya Therapy uses low-voltage, stereotactic, highly targeted X-rays for treatment of wet AMD — offering a new option for patients worldwide.
The non-invasive Oraya Therapy is rapid, comfortable for the patient, and easy for a trained operator to perform. Recently, the INTREPID (IRay Plus Anti-VEGF Treatment for Patients with Wet AMD) clinical study demonstrated that a wet AMD patient population, previously treated with anti-VEGF for up to three years, experienced a 32% reduction in the number of injections, and had substantially drier retinas, in the Oraya Therapy group compared to controls who did not receive radiation. Additionally, 25% of the Oraya Therapy patients needed no further injections during the first year of follow-up. The mean visual acuity of the Oraya Therapy group was maintained compared to controls, even though significantly fewer injections were administered in this cohort.
Device and Therapy Description
Oraya Therapy is designed to stereotactically deliver low-voltage X-rays for the treatment of CNV due to AMD. With a relatively small footprint of approximately 1.5 x 2 meters (4 x 6 feet) the IRay® Radiotherapy System has been designed for installation in a typical medical office, without need for added room shielding. The operator is positioned on the opposite side of a built-in lead screen, and the low-energy beam is tightly collimated so that no intrinsic radiation protection, such as a leaded apron, is required for the patient.
The system consists of key proprietary elements:
Low-Energy X-ray Tube
Although similar to a portable chest X-ray machine, the tube utilized by the IRay System produces a narrow, highly collimated beam. It is designed to affect only the target area or lesion, with minimal scatter onto surrounding healthy tissue.
Self-contained Automated Beam Positioning System
This positioning mechanism ensures the precise entry of energy into the eye, avoiding critical structures such as the lens and optic nerve.
Oraya Therapy Software
The specialized software manages treatment planning, monitoring and verification. The treatment-planning model uses globe axial length, obtained via immersion ultrasonography or optical biometry, to calculate the exact required beam positioning.
I-Guide™ Eye Stabilization Device
This component has been designed to stabilize and align the eye for accurate delivery of radiation. It includes a sterile, disposable contact lens that uses light suction to hold the eye in the appropriate treatment orientation. The I-Guide also includes optical reflectors that work with the beam positioning system to enable precise localization and tracking of the eye.
Eye Tracking System
The Oraya device continuously monitors movement of the patient’s eye. Radiation delivery shuts down immediately in the event of excessive eye motion.