|Oraya's X-ray system for delivering radiation to the back of the eye--Courtesy of Oraya|
2014 Fierce 15 member Oraya Therapeutics seeks to reduce the number of eye injections required to treat wet age-related macular degeneration, the leading cause of blindness in the developed world. Its CE-marked X-ray device safely delivers radiation to the back of the eye, improving the efficacy of anti-VEGF injectable eye drugs like Genentech's Lucentis.
Early, real-world results are promising. Patients who received the Oraya Therapy treatment in commercial settings experienced a 40% to 74% reduction in the number of injections required to maintain vision after one year, ophthalmologists announced at the European Society of Retina Specialists meeting in Nice, France.
"During the one-year follow-up, we see a drying of the retina and therefore are able to extend the patients' anti-VEGF treatment intervals over the long-term after Oraya Therapy, which is very encouraging," said Dr. Katja Hatz, from the Vista Klinik-EyeRAD Swiss Medical Center in Basel, Switzerland, in a statement.
In addition, the therapy resulted in not only fewer injections but improved outcomes, according to consultant ophthalmic surgeon Christopher Brand of the U.K.'s Royal Hallamshire Hospital. While patients who received the therapy showed improved vision, "equivalent patients not receiving Oraya Therapy did not experience any vision gain over the same period," he said in a statement.
Patients in a previous, sham-controlled clinical trial of the device who met the responder profile were offered the treatment commercially. In the trial, Oraya Therapy patients with fluid in the retina and a lesion size of 4 millimeters or experienced a mean 45% reduction in injections over the subsequent two years, and nearly a quarter needed no additional injections; a broader cohort including patients not as well suited for the treatment experienced a mean reduction of 25%.
Prior to the advent of Oraya's X-ray device and the associated 20-minute procedure, "the ability to deliver a targeted dose of radiation to the precise point in the eye was seemingly insurmountable," Oraya CEO Jim Taylor told FierceMedicalDevices in a previous interview.
Regular injections of anti-VEGF have been proven effective in clinical trials. But, "in the real world having patients maintain that level of monitoring and therapy just does not happen," Taylor during the interview, citing the classical medical problem of nonadherence, which stems from patients' dislike of invasive procedures and injections, as well as the medications' cost (about $2,000 per injection in the U.S.).
Oraya's X-ray therapy is priced so that it pays off in savings from the reduction in injections in about half a year, Taylor said during the previous interview.
The Oraya Therapy is commercially available at 11 eye care sites in Europe. More than 500 patients have received it commercially in Switzerland, Germany and the U.K. The company is looking to expand the number of clinics in the U.K. and Germany offering the device and associated procedure over the coming months.
Oraya pulled off a $42 million Series C funding round in 2009 and last year received a National Institutes of Health grant to study applications of its novel radiation therapy against eye cancer when used in conjunction with gold nanoparticles.
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Special Report: FierceMedicalDevices' 2014 Fierce 15 - Oraya Therapeutics - 2014 Fierce 15