LAKE FOREST, Calif.--(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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190501005854/en/
Brian Moore
Sr. Director, Investor, Media Relations and Corporate
Development
(626) 303-7902, Ext. 3023
[email protected]
Source: STAAR Surgical Company
