FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction

New FDA expansion of U.S. age indication extends EVO ICL use for patients 21 to 60 years old – making EVO ICL available to nearly 8 million additional refractive patients

Lens-based vision correction with EVO ICL is now the leading procedure for U.S. patients with -8.0 diopters and above

U.S. refractive market continues to shift away from laser-based refractive procedures that require corneal tissue removal

LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded age indication for EVO/EVO+ Visian® Implantable Collamer Lenses, extending use to patients 21 to 60 years old. The approval came shortly after publication of three-year FDA clinical trial safety data, reinforcing the long-term safety profile of the EVO ICL.¹ The EVO ICL was previously approved for U.S. patients 21 to 45 years old. The age range indication expansion helps to further increase the addressable market for the EVO ICL in the U.S. and allow its benefits to be brought to more patients. The achievement of the age range expansion in the U.S. is part of a continuing STAAR effort to expand our EVO ICL offering to a broader patient population globally.

A Shift in Patient Preference

The additional approval comes amid a notable shift in the U.S. refractive vision correction market. Laser-based refractive procedures that require corneal tissue removal are at a multi-decade low, declining nearly 40% over the past three years.² Meanwhile, EVO ICL implantations in the U.S. have been growing. Recent patient research indicates that more than half (53%) of U.S. vision correction consumers are now interested in alternatives to LASIK,³ signaling a meaningful change in how patients approach refractive care.

Evolving the Treatment Paradigm for High Myopia

This shift away from laser-based procedures is particularly evident among patients with higher levels of myopia (nearsightedness). A recent AECOS study across 19 U.S. practices, helmed by industry-leading surgeons in the refractive space, found that EVO ICL was the most-performed refractive procedure (72%) in patients with -8.0 diopters and above, indicating that lens-based solutions are increasingly shaping the treatment approach for high myopia.⁴

Long-Term Safety

In parallel with these market trends, long-term clinical evidence for EVO ICL continues to strengthen. In the FDA clinical trial, 629 eyes were followed for three years, demonstrating a strong safety profile with a safety index of 1.25 at three years, no reported cases of pupillary block or pigment dispersion, and a low incidence of anterior subcapsular cataract (0.16%).¹ These outcomes are consistent with published global literature on the EVO platform.

“The AECOS study offers a real-world snapshot of where refractive surgery is heading in the U.S.,” said Warren Foust, Interim Co-CEO, President and Chief Operating Officer of STAAR Surgical. “Across 19 leading refractive practices, EVO ICL accounted for more than 70% of procedures in patients with -8.0 diopters and above. When experienced surgeons consistently favor a lens-based approach for high myopia, it reflects a clear shift in treatment patterns. Combined with long-term FDA safety data and the expanded age indication, we believe EVO ICL is helping define the future pathway for treating a broad range of myopia.”

An estimated 24 million U.S. adults with myopia, including nearly 8 million adults between 46-60, may be potential candidates for EVO ICL, a biocompatible, implantable lens designed to correct distance vision while preserving both the cornea and the natural lens of the eye.⁵ Outside the United States, EVO lenses have been widely used in patients across the 21–60 age range for many years, with patients in the 46-60 age range making up an average of 6% of the total EVO ICL patient base in markets where the product is indicated for patients up to age 60. Clinical experience and more than 100 peer-reviewed studies have demonstrated the safety and effectiveness of the EVO ICL platform.

By preserving corneal tissue and the eye’s natural crystalline lens, EVO ICL offers a reversible, lens-based approach to vision correction that maintains future treatment flexibility. For many patients, this supports a longer-term vision care strategy by providing visual freedom today while allowing surgeons to tailor future solutions as visual needs evolve over time.

EVO lenses are implanted in a quick, minimally invasive procedure in which the lens is positioned behind the iris and in front of the natural crystalline lens. In the U.S., EVO Visian ICL (Implantable Collamer Lens) is indicated for use in phakic eye treatment in patients 21–60 years of age:

• for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane;
• for the correction/reduction of myopic astigmatism in patients with spherical equivalent ranging from -3.0 D to -20.0 D with cylinder of 1.0 D to 4.0 D at the spectacle plane;
• 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 1 year prior to implantation).

For more information about EVO Implantable Collamer® Lenses, please visit EVOICL.com.

¹EVO | EVO+ Visian ICL Directions for Use
²RSC Q4, 2024 Report
³Consumer Survey Conducted By: In-House Research, August 2025.
⁴AECOS US Refractive Surgery Study Data 2024, n=1,882 procedures, Internal Data on File.
⁵Market Scope 2025 Refractive Error Model

About STAAR Surgical

STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR® ICLs are clinically proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 3.5 million ICLs in over 75 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit www.staar.com.

Important Safety Information for EVO ICL

The EVO Visian ICL lens is intended to correct/reduce nearsightedness between -3.0 D up to -20.0 D and treat astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before. Since implantation of the EVO Visian ICL is a surgical procedure, before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. You should NOT have EVO Visian ICL surgery if your doctor determines that 1) the shape of your eye is not appropriate, 2) you do not meet the minimum endothelial cell density for your age at the time of implantation, 3) you have moderate to severe glaucoma, 4) your vision is not stable; or 5) if you are pregnant or nursing.

For additional information with potential benefits, risks and complications please visit evoicl.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often contain words such as “anticipate,” “believe,” “expect,” “plan,” “estimate,” “project,” “continue,” “will,” “should,” “may,” and similar terms. All statements in this press release that are not statements of historical fact are forward-looking statements. These forward-looking statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from what is expressed or implied by the forward-looking statements, including, but not limited to: our ability to grow or generate profit; the willingness of surgeons and patients to adopt a new or improved product and procedure; and other important factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 27, 2024 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission (the “SEC”) and available in the “Investor Information” section of the Company’s website under the heading “SEC Filings,” as any such factors may be updated from time to time in the Company’s other filings with the SEC. Forward-looking statements speak only as of the date they are made and, except as may be required under applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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