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Oraya Therapeutics Achieves Successful INTREPID Study Outcomes with a Non-Invasive Radiation Therapy for Wet AMD

Thu, 05/03/2012 - 6:22am
NEWARK, Calif.--(BUSINESS WIRE)--Oraya Therapeutics, Inc. today announced that the INTREPID clinical trial of radiation therapy has met its primary endpoint of reduction in anti-VEGF injections for patients with wet age-related macular degeneration (wet AMD). The INTREPID study is the first sham-controlled double-masked trial to evaluate the effectiveness and safety of a one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD. Preliminary result analyses found no indication of radiation-related adverse events at the one-year trial end point. The results from the INTREPID study will be presented during the EURETINA Congress in Milan, Italy (September 6-9, 2012).

Enrollment in the INTREPID trial was completed on April 15, 2011 - with 230 subjects. All patients had previously received at least three anti-VEGF injections in the prior year and required further anti-VEGF treatment. Within two weeks following injection, one third of the subjects received a sham exposure and the remainder received a radiation dose of either 16 or 24 Gray (Gy). They were then followed monthly and treated with anti-VEGF (Lucentis®) as needed according to specified reinjection criteria. The multi-national study included sites in Austria, Czech Republic, Germany, Italy and the United Kingdom.

“We are truly grateful to all those who participated in this important study,” said Jim Taylor, CEO of Oraya Therapeutics. “We are excited about the opportunity to bring this important technology and its benefits to physicians, patients, and their families to help ease the burden and cost associated with the treatment of this difficult disease. Our intent is to focus our early commercial efforts in the countries that were part of the trial, and we expect that the first participating sites will initiate treatments within the next few months.”

Wet AMD, a disease characterized by abnormal growth of blood vessels in the macula, is responsible for the vast majority of severe vision loss in the industrialized world. If left untreated, it can quickly lead to the rapid deterioration of visual acuity and blindness. While there is no cure for wet AMD, the expense and burden of current treatment methods, which involve near-monthly injections into the eye, have driven the development of novel approaches such as the Oraya Therapy™. “The success of a trial such as INTREPID will be very meaningful in the scientific and medical community,” stated Peter Kaiser, M.D. of Cleveland Clinic. “The ability to offer our patients a therapy option that could reduce the number of injections for treatment of wet AMD would benefit millions who suffer from this debilitating disease.”

The Oraya Therapy uses low-energy, highly targeted X-rays for treatment of wet AMD. Intended as a one-time procedure, it is non-invasive, rapid, 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 IRay is a CE marked medical device. In the United States the IRay system is limited by U.S. Federal law to Investigational Use. For more information, please visit www.orayainc.com.

About Oraya Therapeutics:

Oraya Therapeutics, Inc. is a privately-held company developing innovative and non-invasive therapies for diseases of the eye. The company was founded in 2007. Its investors include Essex Woodlands Health Ventures, Domain Associates, Scale Venture Partners, and Synergy Life Science Partners. More information about Oraya Therapeutics can be found at www.orayainc.com.

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