FDA expands age indication for STAAR’s EVO ICL to patients aged 21–60 years

STAAR Surgical Company announced that the FDA has approved an expanded age indication for its EVO/EVO+ Visian Implantable Collamer Lenses, extending use to patients ages 21 to 60 years. The EVO ICL was previously approved in the US for patients ages 21 to 45 years.

The approval follows publication of three-year FDA clinical trial safety data involving 629 eyes. At 3 years, the safety index was 1.25, with no reported cases of pupillary block or pigment dispersion and a 0.16% incidence of anterior subcapsular cataract. According to the company, these findings are consistent with published global literature on the EVO platform.¹

STAAR said the expanded age range increases the addressable US market and is part of ongoing efforts to broaden the EVO ICL offering globally.¹

The company cited market data indicating changes in refractive procedure trends. Laser-based refractive procedures that require corneal tissue removal have declined nearly 40% over the past three years. Meanwhile, EVO ICL implantations in the United States have been increasing. Patient research found that 53% of U.S. vision correction consumers are interested in alternatives to LASIK.¹

In addition, a recent AECOS study across 19 U.S. practices reported that EVO ICL was the most-performed refractive procedure (72%) in patients with -8.0 diopters and above.¹

“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, in the release. “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 ages 46 and 60, may be potential candidates for EVO ICL. The lens is designed for phakic eye treatment to correct or reduce myopia ranging from -3.0 D to -20.0 D, and myopic astigmatism with cylinder from 1.0 D to 4.0 D, in patients with an anterior chamber depth of at least 3.00 mm and stable refraction within 0.5 D for one year prior to implantation.¹

Outside the US, EVO lenses are indicated for patients ages 21 to 60, with individuals ages 46 to 60 representing an average of 6% of the total EVO ICL patient base in those markets. EVO lenses are implanted behind the iris and in front of the natural crystalline lens in a minimally invasive procedure.¹

Reference:

1. FDA expands US age indication for EVO ICL as long-term safety data reinforces market shift away from laser vision correction. News release. STAAR Surgical Company. February 17, 2026. Accessed February 20, 2026. https://investors.staar.com/news-and-events/press-releases/2026/02-17-2026-210124036