Receives CE Mark Approval from European
Notified Body
EVO Viva Implantable Collamer® Lens
Corrects Near, Intermediate and Distance Vision
STAAR Surgical Company (NASDAQ: STAA), a leading developer,
manufacturer and marketer of implantable lenses and companion
delivery systems for the eye, today announced that EVO
Viva™, STAAR’s innovative presbyopia correcting implantable
Collamer® lens (“ICL”), has been approved for sale. STAAR received
CE Mark approval of the presbyopic indication for its EVO+ Visian®
ICL with Aspheric (EDOF) Optic, commercially marketed as “EVO
Viva”, from its European Notified Body, DEKRA, on July 2,
2020. EVO Viva will initially be available to patients
through select eye doctors in Spain, Germany and Belgium. Broader
availability of the lens will follow in Europe and other markets
recognizing the CE Mark over the coming months. An introductory
video highlighting EVO Viva’s market positioning for
countries that accept the CE Mark is included with this press
release.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20200707005258/en/
"The launch of EVO Viva significantly expands the market
opportunity for our EVO family of lenses to now include lenses for
patients suffering from presbyopia in the over 30 countries that
currently recognize the CE Mark,” said Caren Mason, President and
CEO of STAAR Surgical. “EVO Viva is a new treatment option
for potential future consideration by the 1.7 billion people
globally with presbyopia1 who may be burdened by reading glasses or
frequent replacement contact lenses. EVO Viva reinforces our
deep commitment to patients seeking visual freedom who have the
express desire to Get Rid of their Reading Glasses. We
believe EVO Viva can represent an attractive alternative
among refractive surgery options currently available in the market
today that require either ablating corneal tissue or removal of
one’s healthy crystalline lens.2 EVO Viva further extends
the renaissance of STAAR’s EVO family of lenses and encourages
broader use of the entire EVO family of lenses.”
STAAR’s lenses have been improving patient vision for over 20
years and more than 1,000,000 ICLs have been implanted by surgeons
with patient satisfaction reported at 99.4%.4 ICL’s are implanted
within the posterior chamber, directly behind the iris, and in
front of the anterior capsular bag. ICLs offer an intraocular
alternative for the correction/reduction of refractive error in
those who currently use spectacles and/or contact lenses for vision
correction.
EVO Viva is STAAR's next-generation implantable Collamer
lens. The lens is designed to work in harmony with a patient's eye
for the correction or reduction of myopia and presbyopia in phakic
and pseudo-phakic (post-cataract IOL) eyes to correct vision. The
innovative EVO Viva lens adds near and intermediate vision
correction for patients with presbyopia. Presbyopia is a normal
age-related loss of vision that makes near objects difficult to see
or blurry, which generally becomes noticeable beginning in the
early-to-mid 40s and continues to worsen.3
A multicenter, prospective clinical investigation demonstrated
the ability of the EVO Viva lens to correct myopia and
presbyopia, resulting in improvement of uncorrected near,
intermediate and distance visual acuity without compromising
quality of vision. Subjects reported significant improvements in
quality of life and high levels of spectacle independence and
satisfaction. A clinical paper authored by the Medical Monitor and
Principle Investigators from the study is being submitted for
publication.
The Directions for Use (DFU) lists the indications as: EVO Viva
TM ICL (Implantable Collamer ® Lens) with Aspheric (EDOF) Optic is
indicated for use in phakic eye treatment in patients 21– 60 years
of age and pseudophakic eye treatment in patients with monofocal
IOLs with and without cylinder correction 21 years of age and older
for:
- The correction/reduction of myopia in patients ranging from
-0.5 D to -20.0 D at the spectacle plane.
- The correction/reduction of myopia with presbyopia in patients
ranging from -0.5 D to -20.0 D at the spectacle plane.
- For extended depth of focus and improved near visual
acuity.
- With an anterior chamber depth (ACD) equal to or greater than
2.8 mm as measured from the corneal endothelium to the anterior
lens capsule.
1 Fricke, Global Prevalence of Presbyopia and Vision Impairment
from Uncorrected Presbyopia, 2018.
2 Laser vision correction procedures ablate corneal tissue and
refractive-clear lens exchange procedures require the removal of
one’s healthy crystalline lens.
3 Mayo Clinic, Patient Care & Health Information, Diseases
& Conditions, Presbyopia, December 2017.
4 Data on file.
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 and STAAR
markets these lenses in over 75 countries. To learn more about the
ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA,
the company operates manufacturing and packaging facilities in
Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. 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: the market opportunity for
EVO Viva, the potential financial impact of EVO Viva’s
availability, product safety or effectiveness, 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 include risks and
uncertainties related to the COVID-19 pandemic and related public
health measures, as well as the factors set forth in the Company’s
Quarterly Report on Form 10-Q for the quarter ended April 3, 2020,
and Annual Report on Form 10-K for the year ended January 3, 2020
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 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,
among others, the following: global economic conditions; the
discretion of regulatory agencies to approve or reject existing,
new or improved products, or to require additional actions;
international trade disputes; and the willingness of surgeons and
patients to adopt a new or improved product and procedure. The
Visian ICL with CentraFLOW, known as EVO Visian ICL, and EVO Viva
not currently approved for sale in the United States.
Important Safety Information for EVO
Viva ICL
Implantation of the EVO Viva ICL is a surgical procedure, and as
such, carries potentially serious risks. The EVO Viva ICL is
designed for the correction/reduction of up to -20 diopters (D) of
nearsightedness with or without presbyopia for patients who are 21
to 60 years of age; and for patients 21 years of age or older who
have been treated with an intraocular lens. Before considering EVO
Viva ICL surgery you should have a complete eye examination and
talk with your eye care professional about the procedure,
especially the potential benefits, risks, and complications. You
should discuss the time needed for healing after surgery.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200707005258/en/
Investors & Media Brian Moore Vice President,
Investor, Media Relations and Corporate Development (626) 303-7902,
Ext. 3023 bmoore@staar.com
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