|[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
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
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.
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.
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.
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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