Devices & Diagnostics, Hospitals, Pharma, Startups

Healthcare startup with noninvasive, one-time wet AMD treatment touts two years of success

Oraya Therapeutics, one of California’s many healthcare startups, has distinguished itself from the crowd. The […]

Oraya Therapeutics, one of California’s many healthcare startups, has distinguished itself from the crowd. The medical device company recently presented results from a two-year study showing its IRay, a low-voltage, stereotactic, radiosurgical system, is able to reduce or halt effects of wet age-related macular degeneration in treated patients and “signifcantly” lower the frequency of anti-VEGF injections for patients.

Wet age-related macular degeneration, AKA wet AMD, is an advanced form of macular degeneration — when poorly formed blood vessels start to form below the point of central vision, Oraya CEO Jim Taylor said. They tend to leak and result in visual distortion, fibrosis scarring and eventually, loss of vision. In fact, he said, there’s only a two-year transition from being diagnosed with wet AMD to total blindness, he said. “Although it affects only 10 to 15 percent of those who have the condition, it accounts for 90 percent of the severe vision loss caused by macular degeneration,” according to AMD.org.

Anti-VEGF therapy proved to be a major breakthrough in treatment for wet AMD. The drugs could halt the progression of the disease and even recapture some lost vision, Taylor said. But the drugs are a chronic therapy. “The patient should go in and see a retinal specialist as frequently as once a month and get an injection in the eye somewhere between six and 12 times a year.”

Ouch. Clearly the drugs are not a medical endpoint.

The broadly inclusive cohort of non-naïve wet AMD patients continued to receive the benefit of a 25 percent mean reduction in anti-VEGF injections over two years. Patients identified in the first year as ideal response candidates maintained an impressive 45 percent mean reduction in anti-VEGF injections through the two-year visit, with superior vision to the non-treated group. In addition, the overall safety profile was positive, with only one percent of treated patients showing evidence of micro-vascular abnormalities due to radiation that could affect vision outcomes.

“The challenge for the last 20 years is how do you safely and effectively radiate the back of the eye,” Taylor said. Oraya’s method offers a one-time, low-energy X-ray therapy; it’s just a one-time radiation intervention. That means less injections with equal or better vision outcomes, Taylor said. But to do that, the company harnesses two important technologies:

  1. A low-energy X-ray source that uses roughly the same power (not dosage) of a dental X-ray
  2. Technology that can control eye motion. With the help of tracking software, the physician positions a proprietary eye-guide lens on the patient’s eye during treatment. A “gentle vacuum” helps ensure that control.

Watch the video above to see a simulation of the technology at work.

The company is currently raising an undisclosed amount of funding that will push the device’s commercialization through to until 2015, Taylor said. Though the company is based in California, it has commercialized its product in Europe first, with no regrets. The 6-year-old company ran clinical trials in Europe from 2010-2011 and had promising first-year results that these second-year results are cementing.

The therapy is commercialized in the United Kingdom. It began in two private eye clinics with patients paying privately. “The purpose for that is to serve as an accelerator for National Health Service hospitals,” Taylor said. Within several months, the company plans to have the therapy available at one or more NHS hospitals on a reimbursed basis, he said.

“Our business is not built around huge numbers of systems, so to cover the UK marketplace, we need 10 to 12 systems,” Taylor said.

Because it’s a one-time treatment, each center can treat a large number of patients and patients would be more willing to travel a bit, he said.

In Switzerland, the Oraya therapy is available at a private eye clinic but is reimburseable. In Germany, Taylor said, nine hospitals with “key opinion leaders” are in the queue, and two should be available for installation and reimbursement early next year. 

Lucentis and Eylea are still the major anti-VEGF pharma players. Potential direct competitors include researchers and startups working on MDM2 inhibitors, which would require anti-VEGF injections less frequently, such as those at University of North Carolina School of Medicine, as well as startups working on other therapeutic devices, such as Arizona-based Salutaris Medical Devices. Bay Area-based NeoVista, a former competitor, recently closed shop after reporting poor Phase III results.

Oraya is backed by venture capital firms including Domain Associates and Essex Woodlands.

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