Oraya Therapeutics has reported positive two-year results from its INTREPID study, designed to evaluate the safety and efficacy of the IRay stereotactic radiotherapy system for the treatment of wet age-related macular degeneration (AMD).
The Oraya Therapy is a non-invasive, low-energy X-ray treatment intended as a one-time procedure to reduce or eliminate the need for frequent anti-vascular endothelial growth factor (VEGF) injections directly into the eye.
Oraya treatment is a simple outpatient procedure, requiring approximately 20 minutes, with no limitations on patient activities after the therapy.
The IRay radiotherapy system’s delivery approach, targeting algorithm, unique eye stabilisation and tracking methods are all key proprietary elements.
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-vascular endothelial growth factor (VEGF) injections for up to two years, experienced a 25% mean reduction in the number of injections.
An analysis of the best responders in the INTREPID trial showed an impressive 45% mean reduction in anti-VEGF injections with better vision outcomes than non-treated patient group.
In addition, only 1% of treated patients showed an evidence of micro-vascular abnormalities due to radiation that could affect vision outcomes.
Post-hoc analysis found patients with significant fluid in the retina at baseline and a lesion size of 4mm or lower in greatest linear dimension as ideal response candidates.
Oraya Therapeutics president and CEO Jim Taylor said: "We welcome the positive year two safety data from the INTREPID trial along with the ability to identify patients who will receive the best outcomes."
The study met primary endpoints, showing that Oraya Therapy significantly reduces the need for anti-VEGF injections for patients with wet AMD, and demonstrated a favorable safety profile.
A total of 21 sites in five European countries participated in the trial, with a total enrolment of 230 patients. A total of 212 patients were followed through the two-year visit.
The full two-year efficacy and safety results will be presented at upcoming EURETINA 2013 in Hamburg, Germany.
IRay has received CE mark but it is currently not available for sale in the US.
According to GlobalData estimates, refractive surgery devices market in the US was valued at $217.4m in 2012 and is expected to grow at a CAGR of 1.1% to reach $234m by 2019.
Image: The IRay radiotherapy system. Photo: courtesy of Oraya Therapeutics, Inc.