STAAR Surgical Announces Expanded Recommended Diopter Range for EVO Visian ICL by Refractive Societies in Germany and Japan
May 01 2019 - 4:10PM
Business Wire
STAAR Surgical Company (NASDAQ: STAA), a leading developer,
manufacturer and marketer of implantable lenses and companion
delivery systems for the eye, today announced the leading
refractive ophthalmic societies in Germany and Japan have increased
the diopter range for recommended use of phakic refractive lenses,
including the EVO Visian ICL, to -3.0 diopters from -6.0 diopters.
A diopter is a unit of measure of the refractive power of a lens
and correlates with the patient’s level of nearsightedness
(myopia/distance vision needs).
The German society, the Kommission Refraktive Chirurgie (KRC),
meaning Commission of Refractive Surgery, which is a joint
commission of two leading German ophthalmic societies, the BVA
(Berufsverband der Augenärzte Deutschlands) and the DOG (Deutsche
Ophthalmologische Gesellschaft), (i) expanded the recommended range
for use of phakic refractive lenses, including the EVO Visian ICL,
from -6.0 diopters (KRC’s prior recommendation) to -3.0 diopters,
and (ii) expanded the ‘border’ recommended range for use from -3.0
diopters (KRC’s prior recommendation) to -1.0 diopters. Separately,
the Japanese Ophthalmological Society modified its surgical
indication criteria for recommended use of phakic intraocular
lenses, such as the EVO Visian ICL, from -6.0 diopters to -3.0
diopters.
Caren Mason, President and CEO of STAAR Surgical, stated,
“Germany and Japan are two highly-respected countries known for
their high regulatory standards, precision and quality.
Historically, phakic intraocular lenses were reserved for patients
with high levels of myopia (greater than or equal to -6.0 diopters)
or those patients who did not qualify for corneal refractive
procedures such as PRK or LASIK. We are delighted that these
esteemed medical societies have updated their guidelines to reflect
their review of contemporary clinical evidence of safety and
effectiveness of phakic refractive lenses, including the EVO Visian
ICL family of lenses and support its use in patients with moderate
levels of myopia, which previously was reserved primarily for
corneal refractive procedures. These recent decisions are
consistent with a growing number of ophthalmic refractive surgeons
who are selecting EVO lenses as a premium and primary solution for
suitable patients with low, moderate or high myopia seeking visual
freedom from spectacles and contact lenses.”
“We are pleased with the modified KRC recommendations and see
ample growth opportunities in the lower diopter segment of
refractive vision correction for the EVO Visian ICL,” said the EVO
Visian ICL Expert Group based in Germany. The group consists of
Drs. Martin Bechmann, Johannes Gonnermann, Laszlo Kiraly, Gero
Krommes, Tobias Neuhann, and Amir Parasta. “The modifications of
KRC recommendations are in line with international practice for the
EVO Visian ICL where low diopters are a focus of refractive
growth,” said Dr. Alonso Juarez of Spain. “I am pleased that after
reviewing the clinical data, the Japanese Ophthalmological Society
modified its guideline for use of the EVO Visian ICL to include
lower diopters in the -3D to -6D range. We believe that EVO is an
important and useful addition to the refractive options available
for these patients in Japan,” said Dr. Kazutaka Kamiya of
Japan.
These decisions do not change the approved labeling of use in
either country; rather, they reflect the contemporary positioning
of phakic refractive lenses, such as the EVO Visian ICL family of
lenses, for patients with low to moderate myopia (distance vision
correction needs). EVO is the latest version of STAAR Surgical
Company’s implantable Collamer® lens (ICL) that works with the
patient’s natural eye to correct vision and provide patients visual
freedom from spectacles and contact lenses.
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”, which includes the EVO Visian ICL™ product line. More than
1,000,000 Visian ICLs have been implanted to date. To learn more
about the ICL go to: www.discovericl.com. STAAR markets lenses in
over 75 countries and had approximately 475 full-time equivalent
employees at December 28, 2018. Headquartered in Lake Forest, 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 financial projections,
including those relating to growth opportunities, expectations for
sales, revenue, or earnings relating to updated recommendations
from ophthalmic societies in Germany or Japan, and any statements
of assumptions underlying any of the foregoing. Important 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
28, 2018 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: global economic
conditions; the discretion of regulatory agencies to approve or
reject existing, new or improved products, or to require additional
actions before approval, or to take enforcement action; potential
international trade disputes; and the willingness of surgeons and
patients to adopt a new or improved product and procedure. The
Visian ICL with CentraFLOW, now known as EVO Visian ICL, is not yet
approved for sale in the United States.
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version on businesswire.com: https://www.businesswire.com/news/home/20190501005854/en/
Brian MooreSr. Director, Investor, Media Relations and Corporate
Development(626) 303-7902, Ext. 3023bmoore@staar.com
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