MONROVIA, Calif., May 11, 2017 /PRNewswire/ -- STAAR Surgical
Company (NASDAQ: STAA) a leading developer, manufacturer and
marketer of implantable lenses and companion delivery systems for
the eye, has received CE Mark for its EVO+ Visian ICL™ with
Aspheric (EDOF) Optic, for commercialization in the European Union
from its Notified Body, DEKRA.
The EVO+ Visian ICL with Aspheric (EDOF) Optic is STAAR's
next-generation lens. The lens is surgically implanted and works in
harmony with the patient's eye to correct vision. Unlike
traditional contact lenses that are placed on the surface of the
eye, the EVO Visian ICL family of lenses is positioned inside the
eye between the iris and the natural lens where it stays
indefinitely.
The EVO+ Visian ICL with Aspheric (EDOF) Optic is indicated for
the correction or reduction of hyperopia and myopia between +3.0
diopters and -18.0 diopters. These lenses include CentraFLOW®
technology, a central port that allows the flow of aqueous humor,
thus eliminating the need for peripheral iridotomies.
The EVO Visian ICL family of lenses offers premium refractive
outcomes with efficiency and comfort for both the patient and the
surgeon. Approximately 285,000 lenses from the EVO Visian ICL
product family have been implanted globally to date. Clinical
data show that the EVO Visian ICL provides outstanding, predictable
correction of a broad range of refractive errors, with the vast
majority of patients achieving and maintaining 20/20 or better
visual acuity through five years of follow up.1 Review
of the peer-reviewed published literature demonstrates an excellent
safety profile: specifically, eight studies, including data from
1,291 eyes followed for up to five years, describe a zero incidence
of significant complications.2
"We are very pleased with the CE Mark approval for the EVO+
Visian ICL with Aspheric (EDOF) Optic. We plan to introduce this
lens to a select group of surgeons for Early Effectiveness
Observational use. This beta analysis is designed to elicit
surgeon feedback on their experience with the EVO+ Visian ICL with
Aspheric (EDOF) Optic including overall performance, patient
acceptance, and practice development. This represents an
important new treatment option for eligible patients between 21 and
45 years of age living with nearsightedness or
farsightedness. This approval reinforces our deep commitment
to patients seeking visual freedom, as we continue to build our
growing EVO Visian ICL portfolio," said Caren Mason, President and CEO.
Clinical Trial for Presbyopic EVO+ Visian ICL Beginning this
Year
As reported recently, the first-in-man clinical trial for the
EVO+ Visian ICL lens designed for the correction or reduction of
presbyopia is underway and continues to be promising.
"Earlier this week, we hosted leading global surgeons at our new
STAAR Technology Center, sharing the science behind our Collamer
material technology and early findings of our Presbyopic initial
clinical trial. The surgeons were pleased with this
investigational use only preview and impressed with the
data. Later this year, we plan to initiate the pivotal
clinical trial supporting the applications for the new EVO+ Visian
ICL for correction or reduction of presbyopia," added Ms.
Mason.
1.
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Shimizu K, Kamiya K,
Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber
Phakic Intraocular Lens With and Without a Central Hole (Hole ICL
and Conventional ICL) Implantation for Moderate to High Myopia and
Myopic Astigmatism. Medicine. 2016
Apr;95(14):e3270.
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2.
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Packer M.
Meta-Analysis and Review: Effectiveness, Safety and Central Port
Design of the Intraocular Collamer Lens (ICL). Clinical
Ophthalmology, 2016;10;1059-1077.
|
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for
over 30 years, designs, develops, manufactures and markets
implantable lenses for the eye with companion delivery systems.
These lenses are intended to provide visual freedom for patients,
lessening or eliminating the reliance on glasses or contact
lenses. All of these lenses are foldable, which permits the
surgeon to insert them through a small incision. STAAR's lens
used in refractive surgery is called an Implantable Collamer® Lens
or "ICL". More than 700,000 Visian ICLs have been implanted
to date. To learn more about the ICL go to:
www.discovericl.com. STAAR has approximately 336 full-time
equivalent employees and markets lenses in over 60 countries.
Headquartered in Monrovia, CA, the
company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. For more information,
please visit the Company's website at www.staar.com.
Safe Harbor
All statements in this press release that are not statements of
historical fact are forward-looking statements, including
statements about any of the following: any projections or
expectations for sales, marketing and clinical initiatives, success
and timing of new or improved products, clinical trials, research
and development activities, performance and significance of a new
product, and any statements of assumptions underlying any of the
foregoing. Important additional factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements are set forth in the Company's Annual
Report on Form 10-K for the year ended December 30, 2016 under the caption "Risk
Factors," which is on file with the Securities and Exchange
Commission and available in the "Investor Information" section of
the company's website under the heading "SEC Filings." We
disclaim any intention or obligation to update or revise any
financial projections or forward-looking statement due to new
information or events.
These statements are based on expectations and assumptions as of
the date of this press release and are subject to numerous risks
and uncertainties, which could cause actual results to differ
materially from those described in the forward-looking statements.
The risks and uncertainties include the following: our limited
capital resources and limited access to financing; the negative
effect of unstable global economic conditions on sales of products,
such as the EVO Visian ICL product family used in non-reimbursed
elective procedures; changes in currency exchange rates; the
discretion of regulatory agencies to approve or reject existing,
new or improved products, or to require additional actions before
approval (including but not limited to FDA requirements and/or
actions related to the FDA Warning Letter and Form FDA-483s), or to
take enforcement action; research and development efforts may not
be successful or may be delayed in delivering products for launch;
the willingness of surgeons and patients to adopt a new or improved
product and procedure; and patterns of EVO Visian ICL use that have
typically limited our penetration of the refractive procedure
market. The Visian Toric ICL and the Visian ICL with
CentraFLOW, now known as EVO Visian ICL, are not yet approved for
sale in the United States.
CONTACT:
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Investors &
Media
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EVC Group
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Brian Moore,
310-579-6199
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Doug Sherk,
415-652-9100
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SOURCE STAAR Surgical Company