FDA Expands Age Indication for STAAR Surgical’s EVO ICL

STAAR Surgical Company’s EVO/EVO+ Visian Implantable Collamer Lenses (ICL) are now suitable for patients aged 21 to 60, under an expanded indication approved by the U.S. Food and Drug Administration (FDA).

The approval coincided with the publication of three-year FDA clinical trial safety data reinforcing the EVO ICL’s long-term safety profile.¹ The EVO ICL was previously approved for U.S. patients 21 to 45 years old. The age range indication expansion further increases the addressable U.S. market for the EVO ICL and enables more patients to benefit from it.

The additional approval occurs 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 United States 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.

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 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

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 eye’s natural lens.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 comprising an average 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 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 is used in phakic eye treatment in patients 21–60 years old:

• for correcting/reducing myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane;
• for correcting/reducing 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 crystalline lens surface;
• and a stable refractive history (within 0.5 D for 1 year prior to implantation).

STAAR Surgical develops 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 designed, developed, manufactured, and marketed advanced Implantable Collamer Lenses 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, Calif., the company operates research, development, manufacturing, and packaging facilities in California and Switzerland.

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