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

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.