FDA Expands Age Range for STAAR Surgical's EVO ICL to Include Patients Up to 60 Years Old
核心洞察
The FDA has approved an expanded age indication for STAAR Surgical (搜索)'s EVO/EVO+ Visian Implantable Collamer Lens (搜索), extending eligibility from ages 21-45 to 21-60 years.
Three-year clinical trial data from 629 eyes demonstrated strong safety profile with no cases of pupillary block (搜索) or pigment dispersion (搜索) and low anterior subcapsular cataract (搜索) incidence.
The approval addresses a growing market shift as EVO ICL (搜索) accounts for 72% of refractive procedures in high myopia (搜索) patients with -8.0 diopters and above.
The U.S. Food and Drug Administration has approved an expanded age indication for STAAR Surgical (搜索)'s EVO/EVO+ Visian Implantable Collamer Lens (搜索), extending eligibility to patients aged 21 to 60 years, up from the previous 21-45 age range. The approval significantly broadens the addressable patient population for the lens-based vision correction technology.
Clinical Trial Data Supports Safety Profile
The expanded indication is supported by robust three-year FDA clinical trial data involving 629 eyes. The study demonstrated what STAAR described as "a strong safety profile" with a safety index of 1.25 at three years. Notably, the trial reported no cases of pupillary block (搜索) or pigment dispersion (搜索), and showed a low incidence of anterior subcapsular cataract (搜索) at 0.16 percent.
The EVO ICL (搜索) is indicated for phakic eyes to correct myopia (搜索) with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane, and myopic astigmatism (搜索) correction in patients with spherical equivalent ranging from -3.0 D to -20.0 D and cylinder of 1.0 D to 4.0 D at the spectacle plane. Patients must have an anterior chamber depth of 3.0 mm or greater and maintain a stable refractive history within 0.5 D for one year prior to implantation.
Market Shift Toward Lens-Based Solutions
The approval comes amid significant changes in the U.S. refractive vision correction landscape. According to STAAR, laser-based refractive procedures requiring corneal tissue removal have declined nearly 40 percent over the past three years, while EVO ICL (搜索) implantations have been growing. Recent patient research indicates that more than half (53 percent) of U.S. vision correction consumers are now interested in alternatives to LASIK.
Data from a multicenter American-European Congress of Ophthalmic Surgery (AECOS) study across 19 U.S. practices involving 1,882 procedures revealed that EVO ICL (搜索) was the most-performed refractive procedure, accounting for 72 percent of cases in patients with -8.0 diopters and above.
"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 (搜索). "Across 19 leading refractive practices, EVO ICL (搜索) accounted for more than 70 percent of procedures in patients with -8.0 diopters and above. When experienced surgeons consistently favor a lens-based approach for high myopia (搜索), it reflects a clear shift in treatment patterns."
Expanded Patient Population
STAAR estimates an addressable population of approximately 24 million U.S. adults with myopia (搜索), including nearly 8 million adults between 46 and 60 years old who could be potential candidates for EVO ICL (搜索). Outside the U.S., EVO lenses have been used in the 21 to 60 age range for many years, with patients aged 46 to 60 representing an average of 6 percent of the EVO ICL patient base in markets where the product is indicated to age 60.
The EVO lenses are implantable, biocompatible lenses placed behind the iris and in front of the eye's natural crystalline lens through a minimally invasive procedure. The technology preserves corneal tissue and the natural lens, offering what STAAR describes as a reversible, lens-based approach that maintains future treatment flexibility.