Oraya Therapy safe and effective for patients with wet AMD

Oraya Therapeutics, Inc. today announced that one of the patients who successfully was treated for wet age-related macular degeneration (AMD) with Oraya Therapy™ during the INTREPID clinical trial has released data showing he has experienced significant, sustained vision improvement more than two years after treatment in his right eye, without any subsequent anti-vascular endothelial growth factor (anti-VEGF) injections or other treatment. The patient, well-known British author Jonathan Gathorne-Hardy, also said he has experienced significantly reduced central vision in his left eye following standard anti-VEGF treatments over the same time period.

The INTREPID trial was the first sham-controlled, double-masked study to evaluate the effectiveness and safety of a one-time radiation therapy, Oraya Therapy, in conjunction with anti-VEGF injections for the treatment of wet AMD. High-level results of the two-year study, which met its primary clinical endpoint, were released at EURETINA in September 2012.

"These life-changing results for patients with wet AMD further underline the efficacy of Oraya Therapy, and are the real source of motivation behind all that we do," said Oraya president and CEO Jim Taylor. "With the ability to improve the vision of wet AMD patients with fewer injections - and in this case no injections at all -Oraya Therapy can offer a more convenient, effective and cost-effective treatment for this debilitating disease."

Mr. Gathorne-Hardy was one of 230 patients enrolled in the multi-national INTREPID study evaluating the 20-minute, non-invasive therapy. He has wet AMD in both eyes, and received the Oraya Therapy at King's College Hospital, London on his right eye in August 2010. After one year, the visual acuity in his right eye was significantly improved, with a vision gain of nine letters on his visual acuity score, and after two years has stabilized at an acuity better than before the Oraya Therapy. He has not received any subsequent anti-VEGF injections into the eye or any other treatment. In contrast, the central vision of Mr. Gathorne-Hardy's left eye, diagnosed in 2008 and treated solely with the standard anti-VEGF injections, was significantly reduced.

All patients in the INTREPID trial previously had received at least three anti-VEGF injections in the prior year and required further anti-VEGF treatment. Within two weeks of receiving the 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.

Results of the trial showed that further injections were reduced by 32 percent in the radiotherapy groups compared with the control group. These radiotherapy groups were twice as likely to receive no injection over the course of a year and were approximately half as likely to need four or more injections over the course of a year. Also, post-hoc analysis looked at the best responders to stereotactic radiotherapy and identified a group of patients which experienced a 54 percent reduction in the number of injections and a mean visual superiority of 6.8 ETDRS letters compared to equivalent patients in the control group.

"The results of the INTREPID study which have been reported to date are encouraging for clinicians and for individuals with wet AMD. The prospect of maintaining vision while needing fewer eye injections will appeal to any patient receiving anti-VEGF therapy, and for certain subsets in the trial there is the added advantage of an improved visual outcome," said Timothy L. Jackson, PhD, FRCOphth, King's College Hospital, London, lead investigator for the trial.

The Oraya Therapy uses low-energy, highly targeted X-rays for treatment of wet AMD and is a non-invasive, one-time intended procedure. It is now available at the Optegra Surrey Eye Hospital in Guildford, United Kingdom, establishing Optegra as the world's first clinical centre to offer Oraya Therapy.

Tim Clover, CEO of Optegra, said: "Optegra treats many patients with AMD and knows the frustration of managing this disease. We are committed to encouraging new therapies that will have a positive impact on patients. Oraya Therapy offers a real benefit to patients and Optegra is proud and excited to be selected as Oraya's launch partner. We are pleased to have the opportunity to work with the innovative and dedicated people of Oraya, and to have the benefit of a scientifically sound clinical trial to support the value and potential of this unique therapy."