After
more than 20 years of research and development, Second Sight Medical
Products, Inc., the leading developer of retinal prostheses for the
blind, announced that it's Argus® II Retinal Prosthesis System
('Argus II')has received U.S.market approval
from the Food and Drug Administration (FDA)
to treat individuals with late stage Retinitis Pigmentosa (RP).
This
announcement follows receipt of the European approval in 2011, and a
unanimous recommendation by the FDA's Ophthalmic Devices Advisory
Panel in September 2012 that this revolutionary product be made
available to treat this patient population in the U.S.
'We
are thrilled to be able to offer the only FDA-approved long-term
therapy for people suffering from advanced RP,' said Robert
Greenberg, MD, PhD, President and CEO of Second Sight. 'With this
approval, we look forward to building a strong surgical network in
the United States and recruiting new hospitals that will offer the
Argus II retinal implant. This is a game changer in sight-affecting
diseases, that represents a huge step forward for the field and for
these patients who were without any available treatment options until
now.'
Argus
II is intended to provide electrical stimulation of the retina to
induce visual
perception in blind individuals with retinitis
pigmentosa and has the capacity to offer life-changing visual
capabilities to those currently unable to see anything except, at
best, extremely bright lights.
Although
the resulting vision is not the same as when these patients had
normal vision, investigators involved in theclinical
trial of the Argus II are eager about the
approval. 'It is incredibly exciting to have FDA approval to begin
implanting the Argus II and provide some restoration of vision to
patients blinded from RP. In the patients that have been implanted to
date, the improvement in the quality of life has been invaluable,'
said Mark Humayun, MD, PhD, Cornelius Pings Professor of Biomedical
Engineering and Professor of Ophthalmology, Biomedical Engineering,
Cell and Neurobiology, Keck School of Medicine of USC and USC
Viterbi School
of Engineering, University
of Southern California.
'The
fact that many patients can use the Argus implant in their activities
of daily living such as recognizing large letters, locating the
position of objects, and more, has been beyond our wildest dreams,
yet the promise to the patients is real and we expect it only to
improve over time.'
With
approval from the FDA, the Argus II is slated to be available later
this year in clinical centers across the country. Second Sight will
be actively adding sites to make the therapy more readily available
and encourages interested facilities and patients to contact them.
'This
is an exciting time for people who are blind from RP. Second Sight's
prosthetic retinal device brings meaningful hope to tens of thousands
of people with advanced retinal diseases,' said Stephen Rose PhD,
chief research officer at Foundation Fighting Blindness. He adds,
'The Argus II has the potential to provide life-changing vision
capabilities as well as increased mobility and independence.'
FDA
approval came following more than 20 years of work in the field, two
clinical trials, over $100M in public investment by the National Eye
Institute, the Department of Energy, and the National Science
Foundation, and an additional $100M in private investments.
About
Retinitis Pigmentosa (RP)
RP,
an inherited retinal degenerative disease that often results in
nearly complete blindness, affects roughly 100,000 Americans. The
Argus II System is intended to help the worst-affected RP patients,
and this approval was made under a Humanitarian Device Exemption
intended to expedite market introduction of technologies
intended to treat smaller, underserved patient populations.
About
the Argus II System
The
Argus II System works by converting video images captured by a
miniature camera housed in the patient's glasses into a series of
small electrical pulses that are transmitted wirelessly to an array
of electrodes on the surface of the retina. These pulses are intended
to stimulate the retina's remaining cells resulting in the
corresponding perception of patterns of light in the brain. The
patient then learns to interpret these visual patterns thereby
regaining some visual function. Second Sight gained European approval
(CE Mark) for the system in 2011 and FDA approval in 2013. It remains
the first and only approved retinal prosthesis anywhere in the world.
About
Second Sight
Second
Sight Medical Products, Inc., located in Los Angeles, California, was
founded in 1998 to create a retinal prosthesis to provide sight to
patients blinded from outer retinal degenerations such as RP. Through
dedication and innovation, Second Sight's mission is to develop,
manufacture and market implantable visual prosthetics to
enable blind individuals to achieve greater independence. US
Headquarters are in Sylmar, CA, and European Headquarters are in
Lausanne, Switzerland. For more information, visit www.2-sight.com
