Study Results Published in Ophthalmology Show Safety and Sustained Improvement in Visual Performance for Blind Patients
The paper entitled "Five year safety and performance results from the
Argus II Retinal Prosthesis System Clinical Trial" follows the
assessment of 30 subjects in the clinical trial (NCT00407602) implanted
with the Argus II in 10 centers throughout
"For patients with RP who are living in darkness, the long-term benefits
of the Argus II in restoring some useful vision represents a very
meaningful milestone," said
"We are excited to see that the substantial visual improvement gained
from the Argus II endures over five years - promising news for patients
blinded by RP, as well as for our company's continued efforts to restore
In the Argus II study, three types of visual function tests were performed using computer-run assessments: square localization (i.e. object detection), direction of motion (i.e. motion detection) and discrimination of oriented gratings (i.e. visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: one test asked patients to locate and touch a door, and the second test asked patients to follow a white line on the floor. The ability to find a door and follow a line have real-world meaning with respect to mobility, ambulation and safety.
Earlier results from this trial were used to gain
Positive results of this long-term clinical study follow news about the
Argus II's long-term cost effectiveness published in 2014. Researchers
evaluated the costs of using the Argus II over 25 years beginning at age
46 (the estimated average age that patients with RP are diagnosed as
legally blind) and found that the incremental cost per ratios for the
Argus II were about
Current research efforts by Second Sight include a feasibility study of the Argus II for individuals with dry age-related macular degeneration; hardware and software upgrades for existing and future Argus II patients; and the development of an advanced visual prosthesis, the Orion™ I Visual Cortical Prosthesis, aimed at patients with nearly all other forms of blindness.
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 (RP). 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 are intended to stimulate the retina's remaining
cells, resulting in the perception of patterns of light in the brain.
The patient then learns to interpret these visual patterns, thereby
regaining some useful vision. The system is controlled by software and
is upgradeable, which may provide improved performance as new algorithms
are developed and tested. The Argus II is the first artificial retina to
receive widespread approval, and is offered at approved centers in
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.
Second Sight is also developing the Orion™ I Visual Cortical Prosthesis
to restore some vision to individuals who are blind due to causes other
than preventable or treatable conditions.
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
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"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 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
1 The paper was electronically published today prior to
publication in Ophthalmology.
2 Vaidya A, Borgonovi E, Taylor RS, et al. The cost-effectiveness of the Argus II retinal prosthesis in Retinitis Pigmentosa patients. BMC Ophthalmol. 2014;14:49.
For Second Sight:
Manager of Professional Relations
Senior Vice President
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