Oraya’s IRay Stereotactic Radiotherapy System Receives CE Mark

Oraya Therapeutics, of Newark, CA, has received CE approval for its IRay stereotactic radiotherapy system. The IRay system is a low-energy, stereotactic radiosurgical device for the office-based, noninvasive treatment of wet age-related macular degeneration (AMD). IRay delivers a precise dose of radiation to the macula using a robotic positioning system, a proprietary localizing algorithm and a novel methodology for eye stabilization. Clinical trials with the system are underway in Europe, in a masked and sham-controlled study intended to demonstrate the efficacy and safety of radiation therapy for the treatment of AMD. The one time radiation treatment is given in conjunction with the current standard of care anti-VEGF drug regimen, and with the expectation that visual acuity outcomes for the treated patients will be maintained with significantly less frequent drug injections as compared to the sham controlled group.
Press release: Oraya Therapeutics Granted European CE Mark for the IRayTM Stereotactic Radiotherapy System… (.pdf)
Company page: Oraya Therapeutics…