STAAR Surgical Gains Supplemental Lens Approval for EVO Visian ICL to Target Post-Cataract Market Opportunity
January 13 2020 - 7:00AM
Business Wire
CE Mark Approval for EVO Visian ICL Product
Family as a Supplemental Lens Offers Unhappy Cataract Patients
Opportunity to Achieve Visual Freedom
CE Mark Addresses Post-Cataract-Surgery Myopia,
Hyperopia and Astigmatism Patients with Residual Refractive
Error
STAAR Surgical Company (NASDAQ: STAA), a leading developer,
manufacturer and marketer of implantable lenses and companion
delivery systems for the eye, is today announcing the Company has
gained CE Mark approval for use of its ICL as a supplemental or
“piggyback” lens in post-cataract IOL surgery patients
(pseudophakics). A supplemental EVO ICL is placed in front of the
cataract IOL lens in post-cataract patients just like the EVO ICL
is placed in front of the human crystalline lens in refractive
patients. The EVO ICL in the post-cataract patient is supplemental
to the cataract IOL. The approval is for STAAR’s EVO/EVO+ and
VISIAN® Implantable Collamer® Lenses for myopia and hyperopia, and
EVO/EVO+ and VISIAN® Toric Implantable Collamer® Lenses for myopia
and hyperopia with astigmatism.
Approximately 28 million eyes undergo cataract surgery each year
globally.1 Data from the European Registry of Quality Outcomes for
Cataract and Refractive Surgery suggest that at least 13% of
cataract patients have significant residual postoperative
refractive error that may be corrected.2 Additional data suggests
that up to 21% of patients with a history of corneal refractive
surgery, including prior LASIK or RK, may need an enhancement
procedure to achieve acceptable vision without eyeglasses or
disposable contact lenses.3
“EVO ICL, implanted as a supplemental lens, offers an important
safety net for a cataract patient’s vision and provides the
opportunity for excellent uncorrected visual acuity and a
spectacle-free lifestyle,” said ophthalmologist Dr. Mark Packer,
President of Mark Packer MD Consulting, Inc. “Multiple authors of
peer-reviewed, scientific publications have already reported
successful deployment of the EVO ICL as a supplemental lens for the
correction of residual refractive error following cataract surgery.
The ability to enhance the outcomes of cataract surgery is
essential for the success of a cataract surgeon’s practice,
particularly when caring for patients who have already demonstrated
their commitment to a spectacle-free lifestyle by having had LASIK
when they were younger. The outstanding effectiveness and
demonstrated safety of EVO implantation in phakic eyes make EVO an
excellent choice for correction of residual pseudophakic refractive
error, especially in those eyes with a history of prior corneal
refractive surgery. Regulatory approval of the EVO ICL family of
lenses for use as a supplemental lens will now provide surgeons
with greater confidence to use this critical tool to help patients
who are dissatisfied with residual refractive error after cataract
surgery.”
Globally, an estimated 131 million eyes had cataract surgery for
the five-year period from 2015 through 2019 according to Market
Scope, an independent Healthcare data market research firm.4
“The ICL’s new CE Mark approval expands the indications for the
EVO Visian ICL product family to include a much-needed therapeutic
option for the population of post-surgery cataract patients that
find themselves back in glasses or contact lenses,” said Caren
Mason, President & CEO of STAAR Surgical. “This new approval
demonstrates the safety, versatility and significant market
opportunity for our EVO ICL family of lenses and supports those
surgeons who are actively building lens-based practices.”
1 Market Scope, September 2019. 2 Lundstr�m M, Barry P, Henry Y,
Rosen P, Stenevi U. Evidence-based guidelines for cataract surgery:
guidelines based on data in the European Registry of Quality
Outcomes for Cataract and Refractive Surgery database. J Cataract
Refract Surg. 2012;38(6):1086–1093. 3 Vrijman V, van der Linden J
W, van der Meulen I J E, et al. Multifocal intraocular lens
implantation after previous corneal refractive laser surgery for
myopia. J Cataract Refract Surg 2017 Jul;43(7):909-914. 4 Market
Scope, IOL Market Report, A Global Analysis, 2016, 2017, 2018,
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 eyeglasses 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
market opportunity and potential commercial and medical
significance of the EVO Visian ICL family of products in the
market, and our ability to obtain and maintain regulatory market
approval. Forward-looking statements are based on our 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 Visian ICL family of products in any
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/20200113005268/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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