STAAR Surgical Announces FDA IDE Clinical Study Approval
August 27 2019 - 7:00AM
Business Wire
EVO/EVO+ VISIAN® Implantable Collamer® Lens
for Myopia, and EVO/EVO+ VISIAN® Toric Implantable Collamer® Lens
for Myopia with Astigmatism
Additional Study Recommendations and
Considerations to be Addressed
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 the FDA in a
letter dated August 23, 2019, stated that it has determined that
STAAR has provided sufficient data to support initiation of a human
clinical study in the United States of the EVO/EVO+ VISIAN®
Implantable Collamer® Lens for Myopia, and EVO/EVO+ VISIAN® Toric
Implantable Collamer® Lens for Myopia with Astigmatism.
FDA also recommended study design modifications, which STAAR
plans to incorporate into the investigational plan in a revised
submission in the coming month. STAAR’s current plan for the study
reflects FDA’s recommendations from on-going interactive dialogue
regarding the investigational protocol, including 300 subjects with
a primary endpoint at six months follow up. Subjects enrolled in
the trial will not undergo planned peripheral iridotomies.
“STAAR looks forward to working with FDA to incorporate the
recommended protocol modifications in order for the study design to
support a marketing approval submission,” said Caren Mason,
President & CEO.
Finalizing the Investigational Device Exemption (IDE) with the
FDA is an important step towards the future availability of the EVO
Visian ICL family of products in the U.S.
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 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 Annual Report on Form 10-K for the year ended
December 28, 2018, under the caption “Risk Factors,” which is 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/20190827005290/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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