Nov 13 2013
NEWARK, California—Patients who suffer from wet age-related macular degeneration (AMD), a leading cause of permanent vision loss, typically have to receive several anti-vascular endothelial growth (anti-VEGF) injections a year to maintain vision. This method of treating wet AMD is not only inconvenient for patients but places a considerable cost burden on the healthcare system. One company that has been working to offer a less invasive, less expensive alternative for wet AMD treatment, says it is currently preparing for commercial expansion in Europe.
Oraya Therapeutics (Newark, California), along with its manufacturing partner OnCore Manufacturing (Fremont, California), has produced the first commercial unit in the U.S. of the IRay radiation system for wet AMD.
IRay, the medical device at the core of Oraya Therapy, is CE marked and is currently available in the UK and Switzerland. The first commercial production comes as Oraya and OnCore have signed a long-term contract to facilitate Oraya’s continued expansion in Europe. Oraya says IRay was developed to offer a non-invasive approach for treating wet AMD and to reduce the number
of anti-VEGF injections into the eye that are the current standard of care. “There is a critical need for new treatments for wet AMD, particularly those that can reduce the burden of anti-VEGF injections. The cost of monthly injections along with the high volume of patients requiring treatment place a strain on healthcare systems and providers, and are exceptionally difficult for patients and caregivers,” said Jim Taylor, president/CEO of Oraya Therapeutics. “We anticipate that Oraya will rapidly ramp up production in the coming months as more clinics offer the therapy and
patient awareness grows.”
Oraya holds 44 patents associated with the IRay system, which consists of a low energy X-ray source that produces a highly collimated narrow beam designed to affect only the target area or lesion, with minimal scatter onto surrounding healthy tissue. A self-contained automated beam positioning system ensures the precise entry of energy into the eye, avoiding critical structures such as the lens and optic nerve. Specialized software ensures accurate treatment planning and precise beam positioning. A proprietary eye stabilization device, working with the beam positioning system, enables precise localization and tracking of the eye. Taylor told Medical Device Daily that the first Baby Boomer won’t turn 70 until about two years from now, and when that generation reaches that age, the problem of wet AMD will become substantially larger than it already is. He also noted that anti-VEGF injections have been a “wonderful advancement” for the disease, but that it comes with a “substantial burden” for patients, physicians, and payers. The cost of the drug itself, the cost of monitoring the patients, and the frequent injections all place a heavy burden on the healthcare system, he said.
The IRay has the potential to be a less expensive and less invasive treatment option for wet AMD while also delivering better patient outcomes. In the company’s INTREPID study, the therapy was shown to reduce the frequency of anti-VEGF injections substantially while maintaining equal to or better than vision in the treated patients compared to their sham counterpart. Also important, the patients who have the most to gain (those who require the most frequent anti-VEGF injections) have been shown to get the best results from the IRay therapy. Taylor said. The company made an important decision early on that it would not manufacture the systems itself but contract with a manufacturing partner, Taylor said, noting that for Oraya, “the therapy is actually the product, not so much the capital equipment.”
By partnering with OnCore, Oraya was able to focus on technology developments and capitalize on the close proximity of OnCore to create an integrated IRay team that was able to reduce time-to-market, the firms said. “The medical device industry is looking for partners with exceptional engineering, supply-chain and manufacturing expertise, which they can leverage to accelerate their
product commercialization process. Many are finding this expertise is here domestically,” said Jajjad Malik, OnCore’s President/CEO. “We worked hand-in-hand with Oraya to manufacture the IRay, and we’re prepared to continue this close partnership as Oraya expands into new geographic markets.”
Oraya was founded in 2007. Its investors include Essex Woodlands Health Ventures (www.ewhv.com), Domain Associates, Scale Venture Partners, and Synergy Life Science Partners. In Europe, the company is focused on three primary countries of interest, Taylor said, Germany, the UK and Switzerland. In the U.S., he said the company has taken lessons from running its European clinical study and has designed a clinical protocol that it will be able to use in the U.S. He said the company is in active communication with the FDA to answer the agency’s questions about that
protocol and is working its way toward running a trial in the U.S. ■
By AMANDA PEDERSEN
Medical Device Daily Senior Staff Writer
Amanda Pedersen, 912-660-2282;