-- Allows patients to have more timely access
to medical devices by expediting their development, assessment, and
review --
Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second
Sight" or "the Company"), a developer, manufacturer and marketer of
implantable visual prosthetics that are intended to create an
artificial form of useful vision to blind patients, today announced
that the U.S. Food and Drug Administration (FDA) has granted
Expedited Access Pathway designation for the Orion™ Cortical Visual
Prosthesis System (Orion). This designation is given to a few
select medical devices in order to provide more effective treatment
of life-threatening or irreversibly debilitating diseases or
conditions. This program is intended to help patients have more
timely access to these medical devices by expediting their
development, assessment, and review.
The FDA has also released a draft guidance document for a
Breakthrough Devices Program, which, when finalized, will supersede
the Expedited Access Pathway. FDA has indicated that all devices
which have EAP designation will gain Breakthrough Device
designation when the guidance document is finalized.
With this designation, Orion will have the following advantages
during the FDA review process:
- Greater interactive review both for the
Investigational Device Exemption and Premarket Approval
application;
- Greater reliance on post-market vs.
pre-market data collection and greater acceptance of uncertainty in
the benefit-risk profile at the time of approval;
- Priority review (i.e., review of the
submission is placed at the top of the review queue and receives
additional review resources); and,
- Senior FDA management involvement and
assignment of a cross-disciplinary case manager
“These advantages potentially allow the FDA to approve Orion
with fewer patients and with a shorter follow-up timeline, thus
facilitating a faster entry of Orion into the commercial market. We
are delighted about the opportunity for patients to have expedited
access to Orion, once approved,” stated Will McGuire, President and
Chief Executive Officer of Second Sight.
Dr. Robert Greenberg, Chairman of Second Sight stated, “FDA’s
Expedited Access Pathway is a game changer for nearly all blind
individuals in the U.S. who currently have no treatment options. We
look forward to moving the program ahead and working with the FDA
in the coming months to map out the most efficient path to market
for this therapy, which has the potential to treat most causes of
blindness.”
Blind patients interested in the Orion clinical trial can
contact Second Sight customer service at 1-855-756-3703 for further
information or referral to one of our clinical trial sites.
About the Orion Visual Cortical Prosthesis System
Second Sight, the manufacturer of the Argus II® Retinal
Prosthesis System (Argus II), has developed a new device, the
Orion. A proof-of-concept clinical trial at UCLA demonstrating the
viability of stimulation of the human visual cortex with a
commercially available device from a different manufacturer was
announced in Q4 2016. First-in-human clinical studies with the
Orion are planned to begin in 2017. Like the Argus II, the idea
behind Second Sight’s Orion is to convert images captured by a
miniature video camera mounted on the patient's glasses into a
series of small electrical pulses. The Orion is designed to
transmit these electrical pulses wirelessly to an array of
electrodes implanted on the surface of the visual cortex, intended
to result in the perception of patterns of light. By bypassing the
retina and optic nerve and directly stimulating the visual cortex,
a cortical prosthesis system has the potential to restore useful
vision to patients completely blinded due to many reasons,
including glaucoma, diabetic retinopathy, or forms of cancer and
trauma – many fold more patients than for the current Argus II
indications. No clinical data is yet available for the Orion.
About the Argus II Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation
that bypasses the defunct retinal cells and stimulates remaining
viable cells inducing visual perception in individuals with severe
to profound Retinitis Pigmentosa. The Argus II works by converting
images captured by a miniature video camera mounted on the
patient's glasses into a series of small electrical pulses, which
are transmitted wirelessly to an array of electrodes implanted on
the surface of the retina. These pulses stimulate the retina's
remaining cells, intending to result in the perception of patterns
of light in the brain. The patient must learn to interpret these
visual patterns, having the potential to regain some visual
function. The Argus II was the first artificial retina to receive
widespread commercial approval, and is offered at approved centers
in Canada, France, Germany, Italy, Russia, Saudi Arabia, South
Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United
States. Further information on the benefits and risks can be found
in the peer reviewed paper at:
http://www.sciencedirect.com/science/article/pii/S0161642016305796
About Second Sight
Second Sight's mission is to develop, manufacture and market
innovative implantable visual prosthetics to enable blind
individuals to achieve greater independence. Second Sight has
developed, and now manufactures and markets, the Argus® II Retinal
Prosthesis System. Enrollment has been completed in a feasibility
trial to test the safety and utility of the Argus II in individuals
with Dry Age-Related Macular Degeneration. New hardware and
software to improve the quality of the vision produced is underway.
A clinical trial to study the Argus II in better-sighted subjects
earlier in the disease was recently approved in Germany. Second
Sight is also developing the Orion™ Visual Cortical Prosthesis to
restore some vision to individuals who are blind due to causes
other than preventable or treatable conditions. U.S. Headquarters
are in Sylmar, California, and European Headquarters are in
Lausanne, Switzerland. For more information, visit
www.secondsight.com.
Safe Harbor
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange and Exchange
Act of 1934, as amended, which are intended to be covered by the
"safe harbor" created by those sections. All statements in this
release that are not based on historical fact are "forward looking
statements." These statements may be identified by words such as
"estimates," "anticipates," "projects," "plans," or "planned,"
"seeks," "may," "will," "expects," "intends," "believes," "should,"
and similar expressions, or the negative versions thereof, and
which also may be identified by their context. All statements that
address operating performance or events or developments that Second
Sight expects or anticipates will occur in the future, such as
stated objectives or goals, or that are not otherwise historical
facts, are forward-looking statements. While management has based
any forward-looking statements included in this release on its
current expectations, the information on which such expectations
were based may change. Forward-looking statements involve inherent
risks and uncertainties which could cause actual results to differ
materially from those in the forward-looking statements, as a
result of various factors including those risks and uncertainties
described in the Risk Factors and in Management's Discussion and
Analysis of Financial Condition and Results of Operations sections
of our Annual Report, on Form 10-K, as filed on March 16,
2017, and our other reports filed from time to time with
the Securities and Exchange Commission. We urge you to
consider those risks and uncertainties in evaluating our
forward-looking statements. We caution readers not to place undue
reliance upon any such forward-looking statements, which speak only
as of the date made. Except as otherwise required by the federal
securities laws, we disclaim any obligation or undertaking to
publicly release any updates or revisions to any forward-looking
statement contained herein (or elsewhere) to reflect any change in
our expectations with regard thereto, or any change in events,
conditions, or circumstances on which any such statement is
based.
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version on businesswire.com: http://www.businesswire.com/news/home/20171108005532/en/
Investor Relations:Institutional
InvestorsIn-Site Communications, Inc.Lisa Wilson, President
212-452-2793lwilson@insitecony.comorIndividual InvestorsMZ North AmericaGreg Falesnik,
Managing Director949-385-6449greg.falesnik@mzgroup.us
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