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Oraya Therapeutics Receives Professional Society Guidance on Use of Radiotherapy for Wet AMD in Germany

Oraya Therapeutics announced today that the German Ophthalmological Society, the Retina Society and the Professional Association of German Ophthalmologists have issued a joint opinion on the adjunctive use of radiotherapy with the IRay® Stereotactic Radiotherapy System for neovascular age-related macular degeneration. The opinion provides guidance for selecting and treating patients with radiotherapy adjunctive to anti-vascular endothelial growth factor (anti-VEGF) therapy in the treatment of wet AMD.

“The joint opinion now provides guidance for ophthalmologists throughout Germany to identify those patients who can benefit from Oraya Therapy for wet AMD. There is a large patient population that does not respond well to anti-VEGF monotherapy, and our aim is to offer these patients in Germany an additional option to maintain their vision and also decrease the burden of frequent injections," said Oraya Therapeutics CEO Jim Taylor. "We are well positioned with our IRay system at major university eye clinics in Germany, and will continue to expand our presence to make the therapy available to the patients who qualify and elect to pursue this alternative.”

The full opinion, titled “Stellungnahme von DOG, RG und BVA zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration“ is accessible within the German Ophthalmological Society website at http://www.dog.org/wp-content/uploads/2015/10/Stellungnahme-RG-DOG-BVA-zur-Strahlentherapie-bei-neovaskul%C3%A4rer-altersabh%C3%A4ngiger-Makuladegeneration.pdf .

More than 550 patients have been treated with Oraya Therapy in three European countries, including Germany, Switzerland and the United Kingdom.

The IRay Radiotherapy system is a CE marked medical device. In the U.S., the IRay system is an investigational device and is not available for sale.

About the INTREPID Study

The INTREPID study was the first to evaluate the safety and efficacy of Oraya Therapy in conjunction with as-needed anti-VEGF injections for patients with Wet AMD, and is the only sham-controlled double-masked trial to assess stereotactic radiotherapy for Wet AMD. The study met primary and secondary endpoints and showed that Oraya Therapy significantly reduces the need for anti-VEGF injections while maintaining vision in the presence of a favorable safety profile. A total of 21 sites in five European countries participated in the trial. Two-year results showed that a broadly inclusive cohort of previously treated Wet AMD patients continued to receive the benefits of a 25 percent mean reduction in anti-VEGF injections over two years. Additionally, the targeted patient population maintained an impressive 45 percent mean reduction in injections through two-year visit, with stable vision.

About Wet AMD

Wet AMD is characterized by abnormal growth of blood vessels in the macula, and is responsible for the vast majority of severe vision loss in the industrialized world. If left untreated, it can 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 have driven the development and commercialization of novel approaches such as the Oraya Therapy.

About Oraya Therapeutics

About Oraya Therapeutics Oraya Therapeutics, Inc. is a privately held company developing innovative and non-invasive therapies for diseases of the eye, including Oraya Therapy for wet age-related macular degeneration. Oraya Therapy is commercially available in the United Kingdom, Germany and Switzerland. Oraya Therapeutics was founded in 2007. Its investors include Essex Woodlands Health Ventures, Domain Associates, and Scale Venture Partners.

For further information on Oraya Therapeutics, go to www.orayainc.com .

Contact:

U.S. Media Contact:
Racepoint Global for Oraya
Susan Thomas, 415-694-6728
sthomas@racepointglobal.com
or
UK and Europe Media Contact:
Racepoint Global for Oraya
Ann-Marie Gannon, + 44 (0) 20 8811 2474
+44 (0) 79 4472 3705 (M)
annmarie.gannon@racepointglobal.com

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