Oraya Therapeutics announced that initial three-year safety follow-up data from its INTREPID study of Oraya Therapy stereotactic radiotherapy for the treatment of wet age-related macular degeneration (AMD) were presented for the first time during the America Academy of Ophthalmology’s (AAO) annual meeting in New Orleans.

The new data from 55 patients who have reached the three-year follow-up visit offer ongoing evidence of Oraya Therapy’s favorable safety profile.

The 36-month follow-up entailed detailed review of color fundus photos and fluorescein angiography, which identifies microvascular changes potentially due to radiation.
Significantly, 2 of 18 patients previously identified with radiation-related microvascular changes showed normalization of the vasculature, and only one new case showed evidence of microvascular change that may have affected vision.

"These new data are very encouraging, especially the normalization of previously identified microvascular changes in selected patients," said Darius Moshfeghi, M.D., of Stanford University’s Byers Eye Institute, who presented the information. "Coupled with a 45 percent reduction in anti-VEGF injections and stable vision over two years for ideal response candidates, the data lend further support of this therapy as an exciting new option in the treatment of wet AMD."

The three-year data follow closely behind the release of the INTREPID two-year results, and the publication of the one-year results in the September 2013 issue of Ophthalmology, the highly respected peer-reviewed journal of the AAO.

The two-year results showed that a broadly inclusive cohort of previously treated wet AMD patients continued to receive the benefit of a 25 percent mean reduction in anti-VEGF injections over two years.

The targeted patient population maintained an impressive 45% mean reduction in injections through the two-year visit, with stable vision.
In two years, half of the patients required only one additional injection beyond baseline and 23 percent required zero additional injections.

Furthermore, the overall safety profile was positive, with only 1% of treated patients showing evidence of microvascular changes due to radiation that could affect vision outcomes.

The ideal response candidates were identified at the one-year time point through post-hoc analysis as patients with significant baseline fluid in the retina and a lesion size of 4 mm or less in greatest linear dimension, corresponding to the diameter of the X-ray treatment beam.

The majority of existing and new wet AMD patients meet these criteria, indicating that the benefits of Oraya Therapy are broadly applicable to the wet AMD patient population.

"Although these data provide early insights into the three-year results of the INTREPID trial, we are very encouraged by the continued demonstration of safety and efficacy of Oraya Therapy. Notably, this initial information provides further validation of the therapy’s potential to ease the burden associated with frequent anti-VEGF injections for patients and physicians alike," said Oraya Therapeutics president and CEO Jim Taylor

"As the population ages, it’s important that new treatments are introduced to meet the challenges posed by the growing number of wet AMD patients. From our experiences with the commercial roll-out of Oraya Therapy in the United Kingdom and Switzerland, we know that retinal physicians appreciate a treatment option that can be administered by a trained operator and that patients are eager for treatments that are non-invasive, quick and require no recovery time."

Three-year safety follow-up data on the full trial cohort are expected in the summer of 2014.

The INTREPID study was the first to evaluate the effectiveness and safety of the Oraya Therapy in conjunction with as-needed anti-VEGF injections, and is the only sham-controlled double-masked trial to assess stereotactic radiotherapy for wet AMD.

The study met primary and secondary endpoints, showing that Oraya Therapy significantly reduces the need for anti-VEGF injections for patients with wet AMD while maintaining vision in the presence of a favorable safety profile.

Twenty-one sites in five European countries participated in the trial, with a total enrollment of 230 patients while 212 patients were followed through the two-year visit.

The Oraya Therapy uses low-energy, highly targeted X-rays for the treatment of wet AMD. Intended as a one-time procedure, it is non-invasive, rapid, relatively comfortable for the patient and easy for a trained operator to perform.

The total procedure time is typically less than 20 minutes. The IRay Radiotherapy System’s delivery approach, targeting algorithm, unique eye stabilization and tracking methods are all proprietary.

The Oraya Therapy was first introduced in the UK and is currently available at the Optegra Eye Hospitals in Guildford and Manchester, as well as the VistaKlinik in Basel, Switzerland.