Staar Surgical announced that the FDA has approved an expanded age indication for its EVO/EVO+ Visian Implantable Collamer Lenses (EVO ICL), extending use to patients aged 21 to 60 years old. The EVO ICL was previously approved in the United States for patients 21 to 45 years old.

The approval follows the publication of 3-year safety data from the FDA clinical trial, further reinforcing the long-term safety profile of the EVO ICL platform. In the study, 629 eyes were followed for 3 years, demonstrating a safety index of 1.25 at 3 years, no reported cases of pupillary block or pigment dispersion, and a low incidence (0.16%) of anterior subcapsular cataract. These findings are consistent with more than 100 peer-reviewed studies supporting the safety and effectiveness of the EVO platform globally.

The expanded age range increases the addressable US market for EVO ICL, enabling surgeons to offer the lens-based solution to a broader segment of adult patients. Staar said the US label expansion is part of its ongoing global strategy to extend EVO ICL access to a wider patient population.

EVO ICL is a biocompatible, implantable lens designed to correct distance vision while preserving both the cornea and the eye’s natural crystalline lens. By maintaining corneal tissue and leaving the natural lens intact, the procedure offers a reversible, lens-based approach that supports future treatment flexibility as visual needs evolve. The lens is implanted during a quick, minimally invasive procedure, positioned behind the iris and in front of the natural crystalline lens.

In the United States, EVO Visian ICL is indicated for use in phakic eye treatment in patients aged 21 to 60 years for:

  • The correction or reduction of myopia ranging from -3.0 D to -20.0 D at the spectacle plane;

  • The correction or reduction of myopic astigmatism with spherical equivalent from -3.0 D to -20.0 D and cylinder of 1.0 D to 4.0 D;

  • Patients with an anterior chamber depth of 3.00 mm or greater, measured from the corneal endothelium to the anterior surface of the crystalline lens; and

  • A stable refractive history (within 0.5 D for one year prior to implantation).