Market Overview

STAAR Surgical Announces Approval by the FDA of the Visian Toric ICL for the Correction of Myopia with Astigmatism


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 has granted approval of the
PMA Supplement for the Visian Toric ICL for the correction of myopia
with astigmatism.

This approval represents a meaningful expansion of the Implantable
Collamer® Lens (ICL) product line for the correction of refractive error
in patients with both myopia and astigmatism which are common conditions
in the United States (US). Astigmatism affects approximately 30 percent
of the population.1

The ICL in both spherical and toric designs has been associated with
significant improvements in quality of life. Patients have described ICL
surgery as "life changing" or wished they had opted for the surgery
sooner.2 The approval of the Visian Toric ICL is also an
important step towards the future availability of advanced ICL models in
the US, such as the EVO/EVO+ Toric ICL.

"FDA's approval of STAAR's Visian Toric ICL in the U.S. provides an
exciting treatment option for myopic patients with astigmatism in search
of visual freedom. We are thrilled to be able to offer this lens in the
United States and look forward to officially making the Visian Toric ICL
available to U.S. surgeons for their patients on November 1st,
2018," said Caren Mason, President & CEO.


The Directions for Use (DFU) lists the indications as: The Visian TICL
is indicated for use in patients 21-45 years of age:

  1. for the correction of myopic astigmatism with spherical equivalent
    ranging from -3.0 D to ≤ -15.0 D (in the spectacle plane) with
    cylinder (spectacle plane) of 1.0 D to 4.0 D in the spectacle plane.
  2. for the reduction of myopic astigmatism with spherical equivalent
    ranging from greater than -15.0 D to -20.0 D (in the spectacle plane)
    with cylinder (spectacle plane) 1.0 D to 4.0 D in the spectacle plane.
  3. with an anterior chamber depth (ACD) of 3.00 mm or greater, when
    measured from the corneal endothelium to the anterior surface of the
    crystalline lens and a stable refractive history (within 0.5 D for
    both spherical equivalent and cylinder for 1 year prior to
  4. The Visian TICL is intended for placement in the posterior chamber
    (ciliary sulcus) of the phakic eye.

1 2017 Refractive Surgery Report: A Global Analysis from 2016
– 2022, Market Scope December 2017

2 Ieong al, Quality of Life in High Myopia before and
after Implantable Collamer Lens Implantation. Ophthalmology

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 900,000 Visian ICLs have been implanted to date. To
learn more about the ICL go to:
STAAR has approximately 400 full-time equivalent employees and markets
lenses in over 75 countries. Headquartered in Monrovia, CA, the company
operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA.
For more information, please visit the Company's website at

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 Visian Toric ICL in the U.S. market.
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.
cannot be certain about the commercial success of the Visian Toric ICL
in the U.S. 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 29, 2017, 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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