STAAR Surgical Announces Submission of Presbyopia Clinical Trial Data; Proprietary EDOF Collamer® Lens is Designed to Improv...
July 31 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 submission of its
multi-site European pivotal clinical trial data for the EVO+
Visian® ICL with Aspheric (EDOF) Optic (“EDOF Lens”), a lens that
is designed to provide correction or reduction of myopia or
hyperopia and presbyopia (the age-related loss of near vision).
Results from the clinical trial were submitted to DEKRA, the
Company’s European Notified Body, earlier this month. If approved,
STAAR’s EDOF lens could be commercially available in countries
recognizing the CE Mark in the second quarter of 2020.
“Our team is pleased to announce our EDOF lens for presbyopia
met the primary performance endpoint of our multi-site European
pivotal clinical trial and that we have recently submitted the data
to our Notified Body for review,” said Caren Mason, President and
CEO of STAAR Surgical. “The trial data confirms our Extended Depth
of Focus (EDOF) lens can provide improved visual acuity for
patients at near, intermediate and far distances. We believe our
EDOF Collamer lenses provide a bilateral treatment for presbyopic
patients enabling true binocular vision at near, intermediate and
far distances. This can represent an attractive solution among
refractive options currently available in the market today that
require either corneal tissue reshaping or removal of one’s healthy
crystalline lens. If approved, we believe our EDOF lens will
further extend the renaissance of STAAR’s EVO family of lenses and
encourage broader use of the entire EVO family of lenses in the 31+
countries that recognize the CE Mark.”
The multi-center European study evaluated the clinical
performance of STAAR’s phakic intraocular lens (IOL), STAAR EVO+
Visian ICL with Aspheric (EDOF) Optic for the improvement of
Uncorrected Near Visual Acuity (UCNVA) in subjects who require
between +1.00 and +2.50 Reading Add.
The primary performance endpoint for the trial, which STAAR
accomplished, was defined as achievement of monocular UCNVA of
20/40 or better at 40 cm (approximately 16 inches) at 6 months
after implantation in equal to or greater than 75% of implanted
eyes. 20/40 generally represents a level of near vision, such as
reading a newspaper, that does not require spectacles.
EVO Visian Implantable Collamer Lenses (ICLs) are intended to be
implanted within the posterior chamber, directly behind the iris,
and in front of the anterior capsule of the human crystalline lens.
It offers an intraocular alternative for the correction/reduction
of refractive error in those who currently utilize spectacles
and/or contact lenses for vision correction. Additional information
on STAAR’s presbyopia clinical trial is available with
ClinicalTrials.gov Identifier: NCT03499821 at
http://www.clinicaltrials.gov.
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: any projections, including
those relating to the approval or success of the EVO+ Visian ICL
with Aspheric (EDOF) Optic or the status of our pipeline of ICL
products with regulators, including the EVO+ Visian ICL with
Aspheric (EDOF) Optic, 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/20190731005908/en/
Investors & Media Brian Moore Sr. Director, Investor,
Media Relations and Corporate Development (626) 303-7902, Ext. 3023
bmoore@staar.com
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