Press Releases 2019

Visual Freedom from Glasses and Contact Lenses Possible with the ICL

Safety and Effectiveness Supported by 100+ Peer-Reviewed Publications and 99.4% Patient Satisfaction¹

Lens Based Solution Addresses Explosive Growth of Myopia Globally

LAKE FOREST, Calif.--(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 that more than one million Visian implantable Collamer lenses (ICLs) have been implanted globally. Currently approved versions of the ICL available in more than 75 countries around the world address the explosive growth of myopia, the need for distance vision correction, that is predicted to impact 50% of the world’s population by the year 2050.² A one minute video celebrating the one million ICL milestone is now available on various apps, websites and at the following link: https://vimeo.com/visianicl/1mmannouncement

“We celebrate the Visian ICL one million lens milestone with our ophthalmology partners, clinicians, and patients who are elevating the ICL to the premium and primary solution for refractive based vision correction,” said Caren Mason, President and CEO of STAAR Surgical Company. “More ICLs have been implanted since 2015 than the prior 15 years of the ICL combined. Today’s milestone represents only the beginning of our journey in raising ICL awareness and adoption to delight surgeons and their patients. The ICL, a remarkable biocompatible lens that works in harmony with a person’s natural eye, is designed to improve vision following a quick 20-30 minute procedure that many patients have described as ‘life changing.’ Through our ICL family of lenses STAAR aims to significantly increase our share of the existing four million annual refractive procedures globally, facilitate the market’s return to peak procedure volumes, and further grow the overall market with new and innovative lenses that address customer demands such as a refractive solution for presbyopia that may eliminate the need for reading glasses. Our work towards future milestones will be bolstered by strong clinical evidence, surgeon training, and ongoing operating and financial discipline.”

The Visian ICL family of lenses are phakic (natural crystalline lens is not removed) intraocular lenses designed to correct for a wide range of vision correction needs including myopia, hyperopia, and astigmatism. The lenses are quiet in the eye. STAAR introduced the first implantable Collamer lens (ICL) for myopia in 1997. U.S. sales commenced in 2006 followed by the introduction of the ICL with CentraFLOW technology outside the U.S. in September 2011 which is now marketed as the EVO Visian ICL. EVO lenses have a port in the center of the ICL optic intended to eliminate the need for a peripheral iridotomy procedure days before the ICL implant. In 2016, STAAR launched Evolution in Visual Freedom websites in major markets, rolled out new marketing material for surgeons and patients, introduced the EVO+ for larger pupil sizes, and began entering into strategic cooperation agreements with leading ophthalmology clinics and surgeons that position the ICL as a premium and primary refractive procedure for vision correction.

To learn more about the ICL please go to: www.discovericl.com

¹ 99.4% of patients in a Patient Registry said they would have the ICL procedure again. Patient Registry data on file.
² Ophthalmology 2016;123:1036-1042 © 2016 by the American Academy of Ophthalmology; Myopia incidence was estimated at 1.4 Billion people globally at time of study growing to 4.8 Billion people by 2050 or predicted 50% of the estimated global population.

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. To learn more about the ICL go to: www.discovericl.com. STAAR markets lenses in over 75 countries and had approximately 475 full-time equivalent employees at December 28, 2018. Headquartered in Lake Forest, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. 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 financial projections, including those relating to the plans, strategies, and objectives of management for 2019 or prospects for achieving such plans, expectations for sales, revenue, or earnings, product safety or effectiveness, 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.

ATTENTION:

For Physicians: Please reference the Visian ICL Product Information for a complete listing of indications, warnings, and precautions.

For Patients: Before considering Visian ICL surgery you should talk with your eye care professional about Visian ICL surgery, especially the potential benefits, risks, and complications.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190410005309/en/

Investors & Media
EVC Group
Brian Moore, 310-579-6199
[email protected]

Doug Sherk, 415-652-9100

Source: STAAR Surgical Company