STAAR Surgical Announces Completion of Patient Enrollment in EVO Implantable Lens US Clinical Trial
September 14 2020 - 7:00AM
Business Wire
Pivotal Study Successfully Enrolls 300 Subjects
Across 14 U.S. Sites
STAAR Surgical Company (NASDAQ: STAA), a leading developer,
manufacturer and marketer of implantable lenses and companion
delivery systems for the eye, is today announcing that patient
enrollment for the primary study analysis cohort of 300 subjects
has been achieved in its U.S. FDA clinical trial, “A Multicenter
Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer®
Lens.” Primary study analysis will be conducted when 300
primary eyes complete 6 months of follow-up, which is anticipated
early in the second quarter of 2021 with submission of the study
results to the FDA shortly thereafter.
“Completion of patient enrollment in the clinical trial is a
critical step towards the future availability of our proprietary
EVO Visian ICL family of products in the U.S. We are very grateful
to our clinical trial sites and study investigators for their
dedicated work and commitment to successfully achieving the trial’s
enrollment milestone in the midst of a challenging COVID-19
operating environment,” said Caren Mason, President and CEO of
STAAR Surgical.
EVO Visian ICLs are intended to treat a wide range of refractive
error, including myopia (nearsightedness) which is the need for
distance vision correction. Myopia is the most common ocular
disorder worldwide and its incidence is increasing rapidly.1
STAAR’s EVO lenses are designed with a central hole, which restores
more natural aqueous flow and eliminates the need for preoperative
peripheral iridotomies. The objective of the U.S. pivotal study is
to evaluate the safety, and to collect supportive data on
effectiveness, of the EVO Visian ICLs in study participants who
have a diagnosis of myopia or myopia with astigmatism. The study
includes the following EVO lenses:
- EVO Visian® ICL for Myopia
- EVO Visian® Toric ICL for Myopia with Astigmatism
- EVO+ Visian® ICL for Myopia
- EVO+ Visian® Toric ICL for Myopia with Astigmatism
By eliminating the need for preoperative peripheral iridotomies
STAAR’s EVO Visian ICL provides a simpler, less time-consuming
procedure for patients seeking visual freedom. Eliminating the need
for preoperative peripheral iridotomies also increases surgeon
efficiency and reduces the number of procedures thereby reducing
the overall cost and complexity while improving the patient
experience and potential positive outcomes.
More than 750,000 EVO Visian® ICLs have been implanted in
patients outside the U.S. Additional details on the U.S. clinical
trial are available on ClinicalTrials.gov here.
1 Neesurg Mehta, MD and Angie Wen, MD, “Myopia: A Global
Epidemic, An Overview of the Problem and Efforts to Address It”,
Eye, Nov/Dec 2019.
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.
Forward-Looking
Statements
This news release contains forward-looking statements. These
statements include but are not limited to statements regarding the
commercial significance of the EVO/EVO+ VISIAN Implantable Collamer
Lens for Myopia, EVO/EVO+ and VISIAN Toric Implantable Collamer
Lens for Myopia with Astigmatism in the US market, the success and
timing of our clinical studies; and our ability to obtain and
maintain regulatory market approval. Forward-looking statements are
based on our management’s current expectations or beliefs regarding
future events or circumstances, and you should not place undue
reliance on these statements. Such statements involve known and
unknown risks, uncertainties, assumptions and other factors, many
of which are out of STAAR’s control and difficult to forecast that
may cause actual results to differ materially from those that may
be described or implied in the forward-looking statements. STAAR
cannot be certain about the regulatory approval or commercial
success of the EVO/EVO+ VISIAN Implantable Collamer Lens for
Myopia, EVO/EVO+ and VISIAN Toric Implantable Collamer Lens for
Myopia with Astigmatism in the US market. For a discussion of
certain other risks, uncertainties and other factors affecting the
statements contained in this news release, see STAAR’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 are on file with the SEC and
available in the “Investor Information” section of STAAR’s website
under the heading “SEC Filings”. Except as required by law, STAAR
assumes no, and hereby disclaims any, obligation to update any of
the foregoing or any other forward-looking statements. STAAR
nonetheless reserves the right to make such updates from time to
time by press release, periodic report or other method of public
disclosure without the need for specific reference to this news
release. No such update shall be deemed to indicate that other
statements not addressed by such update remain correct or create an
obligation to provide any other updates.
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version on businesswire.com: https://www.businesswire.com/news/home/20200914005229/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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