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TMCNet:  New Therapy for Wet AMD Launched by Oraya Therapeutics and Optegra Eye Hospital Group

[December 13, 2012]

New Therapy for Wet AMD Launched by Oraya Therapeutics and Optegra Eye Hospital Group

NEWARK, Calif. & LONDON --(Business Wire)--

Oraya Therapeutics, Inc. announced today that an agreement has been reached with UK specialist eye hospital group Optegra, to establish Optegra as the world's first clinical centers to offer Oraya Therapy™ Stereotactic Radiotherapy for the treatment of wet Age-related Macular Degeneration (AMD (News - Alert)).

Oraya Therapy is a breakthrough new treatment for wet AMD, a disease responsible for the vast majority of severe vision loss in the industrialized world and characterized by abnormally fragile and leaky blood vessels that grow behind the retina's area of central vision.1 The accumulation of fluid and scarring can damage visual cells and quickly progress to loss of central vision.

The recommended therapy for the disease currently requires monthly evaluation and treatment by an ophthalmic specialist, with frequent injections of a drug (anti-VEGF) directly into the eye to inhibit the leakage and formation of new blood vessels. The Oraya Therapy is a non-invasive, low energy X-ray treatment intended as a one-time procedure to reduce or eliminate the need for chronic injections while preserving or enhancing the patient's vision outcomes. The treatment, delivered by the IRay® Radiotherapy System, is a simple outpatient procedure, requiring approximately 20 minutes, with no limitations on patient activities after treatment.

The revolutionary new therapy will first be offered at Optegra Surrey Eye Hospital in Guildford. The agreement was reached shortly after Oraya released data from a successfully completed clinical trial (The INTREPID Study) involving 21 sites and conducted in the UK and four other European countries.

Ophthalmic surgeon at Optegra, Andy Luff, commented: "Wet AMD currently affects approximately 260,000 people in the UK2, and it is projected that nearly 40,000 new people will be affected each year. The chronic injection therapies currently in use often require six to eight injections per year placing an unsustainable and costly burden on the National Health Service (NHS), on patients and on their families."

Gareth Steer, Managing Director for Optegra, said: "Optegra is excited to have been selected to offer the Oraya Therapy as a treatment option that can help to mitigate this critical problem. 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."

The results of the INTREPID trial for radiation therapy for wet AMD were presented on September 8, 2012 to the European ophthalmic community during the 12th EURETINA Congress in Milan. The sham controlled, double-masked study demonstrated a statistically significant reduction in as-needed injections after one year. The actively treated patients required 32 percent fewer injections than the sham group with similar or better visual acuity outcomes.

In addition, a definedpopulation sub-group comprised of half of the study participants experienced injection rate reductions of approximately 50 percent while exhibiting meaningful vision benefit compared to sham. In this population, 30 percent of the treated patients required no further injections for the one year trial duration. Only five percent of the sham patients experienced that result. There were no radiation related safety events identified in any of the patients at the one year trial end point, with 25 percent of these patients having already reached a two year evaluation milestone.

In commenting on the choice of Optegra and the UK for the global introduction of the therapy, Jim Taylor, CEO of Oraya Therapeutics, said: "We are exceptionally proud and pleased to have partnered with Optegra, an organization that shares our values regarding the importance of good science, a focus on services that offer better patient outcomes and greater cost effectiveness, and with a commitment to the highest standards of quality and patient care. Bringing the therapy to the UK also provides us the opportunity to address a recognized and urgent need within the NHS for better therapeutic solutions, and we look forward to working with Optegra and the NHS to expand the access and availability of this important therapy in the months ahead."

The IRay is a CE marked medical device. In the U.S., the IRay System is an investigational device and is not available for sale. For more information, please visit www.orayainc.com and www.optegra.com.

Notes to editors:

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 (News - Alert) Life Science Partners. More information about Oraya Therapeutics can be found at www.orayainc.com.

About Optegra:

Leading specialist eye hospital group, Optegra, is committed to the development of eye sciences and championing the latest innovations in vision correction through its dedicated Eye Sciences Division. Optegra achieves this by partnering with leading UK universities in the research and development of the next generation of ophthalmic services and technologies. In addition, its Professional Partnership Programme of education and development with optometrists and opticians ensures the very best medical treatments are available to all.

To maintain Optegra's five star standard of patient care and safety, its specialist eye hospitals draw on the expertise of its Medical Advisory Committees (MAC), headed by consultant level ophthalmic surgeons who all report into the corporate MAC. This is managed by Medical Director Mr. Robert Morris, who determines Optegra's policies and procedures.

Optegra operates six private eye hospitals: Optegra Eye Hospital, London, Optegra Surrey Eye Hospital (Guildford), Optegra Birmingham Eye Hospital (Aston), Optegra Yorkshire Eye Hospital (Apperley Bridge and Laser Eye Centre in Leeds City Centre); Optegra Solent Eye Hospital (Whiteley) and Optegra Manchester Eye Hospital (Didsbury); as well as locations in Germany and further UK clinics.

All Optegra hospitals are supported by dedicated optometrists and dedicated ophthalmic clinical team which includes registered nurses and health care technicians and over 70 consultant level ophthalmic surgeons who provide a wide range of procedures including Clarivu (refractive lens exchange), laser vision correction, cataract removal, glaucoma, AMD and cosmetic procedures.

www.optegra.com

1 http://europepmc.org/abstract/MED/11816915/reload=0;jsessionid=2KJin304jy5kF579iqWw.6 Age-related macular degeneration, AMD, is the commonest cause of legal blindness in the industrialized world. AMD has two major phenotypes: wet and dry. Most severe visual losses are caused by wet AMD, where new blood vessels form under the macula.

2 http://bjo.bmj.com/content/early/2012/02/02/bjophthalmol-2011-301109.full These estimates applied to the UK population result in approximately 513 000 prevalent cases of late AMD (95% Cr I 363 000 to 699 000), 276 000 cases of GA (95% CrI 188 000 to 396 000) and 263 000 cases of NVAMD (95% CrI 185 000 to 361 000).


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