{"id":62658,"date":"2026-02-17T22:06:37","date_gmt":"2026-02-17T21:06:37","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-expands-u-s-age-indication-for-evo-icl-as-long-term-safety-data-reinforces-market-shift-away-from-laser-vision-correction\/"},"modified":"2026-02-17T22:06:37","modified_gmt":"2026-02-17T21:06:37","slug":"fda-expands-u-s-age-indication-for-evo-icl-as-long-term-safety-data-reinforces-market-shift-away-from-laser-vision-correction","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-expands-u-s-age-indication-for-evo-icl-as-long-term-safety-data-reinforces-market-shift-away-from-laser-vision-correction\/","title":{"rendered":"FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction"},"content":{"rendered":"
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\nNew FDA expansion of U.S. age indication extends EVO ICL use for patients 21 to 60 years old \u2013 making EVO ICL available to nearly 8 million additional refractive patients<\/i><\/p>\n

\nLens-based vision correction with EVO ICL is now the leading procedure for <\/i>U.S. patients with -8.0 diopters and above<\/i><\/p>\n

\nU.S. refractive market continues to shift away from laser-based refractive procedures that require corneal tissue removal<\/i><\/p>\n

LAKE FOREST, Calif.–(BUSINESS WIRE)–STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer\u00ae Lenses (EVO ICL\u2122) for vision correction, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded age indication for EVO\/EVO+ Visian\u00ae 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<\/sup> 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.<\/p>\n

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\nA Shift in Patient Preference<\/b><\/p>\n

\nThe 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<\/sup> 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<\/sup> signaling a meaningful change in how patients approach refractive care.<\/p>\n

\nEvolving the Treatment Paradigm for High Myopia<\/b><\/p>\n

\nThis 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<\/sup><\/p>\n

\nLong-Term Safety<\/b><\/p>\n

\nIn 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<\/sup> These outcomes are consistent with published global literature on the EVO platform.<\/p>\n

\n\u201cThe AECOS study offers a real-world snapshot of where refractive surgery is heading in the U.S.,\u201d said Warren Foust, Interim Co-CEO, President and Chief Operating Officer of STAAR Surgical. \u201cAcross 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.\u201d<\/p>\n

\nAn 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 <\/sup>Outside the United States, EVO lenses have been widely used in patients across the 21\u201360 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.<\/p>\n

\nBy preserving corneal tissue and the eye\u2019s 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.<\/p>\n

\nEVO 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\u201360 years of age:<\/p>\n