ORAYA FOR AMD

Jim Taylor, president and CEO of Oraya Therapeutics, has seen first-hand how difficult repeated anti-VEGF injections can be on patients. Several years ago his mother was diagnosed with neovascular age-related macular degeneration, and received over 25 intraocular injections. “I know how difficult and unsustainable that is,” said Mr Taylor, who has 30 years of executive experience in medical technology. His mother’s experience is one reason Mr Taylor, who was CEO at Carl Zeiss Meditec Inc at the time, got involved with Oraya. The firm’s targeted X-ray treatment approach held promise for reducing the frequency of injections needed to treat wet AMD.

That promise is now a reality. At the one year end point of a sham controlled trial, patients already undergoing anti- VEGF monotherapy who received a single treatment with the Oraya Therapy™ Stereotactic Radiotherapy device required 32 per cent fewer injections of ranibizumab to control their disease. Perhaps just as significant, the trial helped identify a group of patients who may benefit even more from the X-ray therapy. Identified at one year through post-hoc analysis of the 230 trial participants in the INTREPID trial, these patients maintained vision with a 45 per cent mean reduction in injections over two years compared to anti-VEGF monotherapy. In addition, 23 per cent required zero injections in two years.

These “target group” patients all had significant fluid in the retina at baseline and lesion sizes of 4mm or less with minimal fibrosis or scarring. The fluid indicates the disease is in a proliferative phase, making it especially responsive to X-ray treatment, while the size allows the 4mm beam of the Oraya device to completely cover the lesion. About 60 to 70 per cent of wet AMD patients meet these criteria, suggesting that Oraya Therapy can be widely used, Mr Taylor said. At two years, just one per cent of patients showed micro-vascular changes that might have some effect on vision. An early look at three-year safety results also show that some of these micro-vascular changes resolved spontaneously, he added.

Commercial launch

The Oraya Therapy device uses a highly collimated low-power X-ray to irradiate AMD lesions from several angles in a procedure that takes about 20 minutes.The X-ray disrupts the proliferation of neovascular endothelial cells but spares surrounding tissue. The successful trial means Oraya Therapy is ready for commercial use. Oraya systems are already up and running at private clinics in the UK, as well as in a clinic in Switzerland. The first commercial unit has been installed in Germany, with commitments of additional sites through 2014, Mr Taylor said. "Based on the potential to achieve equal or better vision outcomes at a reduced treatment burden, we have the support of some of the top retinal specialists in Germany,” Mr Taylor said. This will make it possible to apply for payment on a basis similar to how Lucentis is paid for in Germany. In the UK, 10 hospital trusts are considering adopting Oraya Therapy.

Oraya Therapy is an obvious addition to the wet AMD treatment paradigm. It’s priced so that it saves money on the overall cost of care, including anti-VEGF agents, staff time and facilities and equipment costs. “This is all made possible by the two-year data. People can see two years of efficacy and cost-benefit data, and we have early threeyear safety data. Now it is a matter of doing the hard work of making the technology available for the patient,” Mr Taylor said. “I only wish it had been available when my mother was diagnosed.”