Staar Surgical Company announced that the US Food and Drug Administration (FDA) has approved an expanded age indication for EVO/EVO+ Visian Implantable Collamer Lenses (ICLs), extending use to patients 21 to 60 years old. The approval came shortly after publication of 3-year FDA clinical trial safety data, reinforcing the long-term safety profile of the EVO ICL, the company said in a press release. The EVO ICL was previously approved for patients 21 to 45 years old in the United States.
According to the company, the age range indication expansion helps to further increase the addressable market for the EVO ICL in the US, and is part of a continuing Staar effort to expand its EVO ICL offering to a broader patient population globally.
In the FDA clinical trial, 629 eyes were followed for 3 years, demonstrating a strong safety profile with a safety index of 1.25 at 3 years, no reported cases of pupillary block or pigment dispersion, and a low incidence of anterior subcapsular cataract (0.16%).
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. 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 US, EVO Visian ICL is indicated for use in phakic eye treatment in patients 21 to 60 years of age for the correction/reduction of myopia in patients with spherical equivalent ranging from -3.0 D to -20.0 D at the spectacle plane; and for the correction/reduction of 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. In addition, it is also indicated for use in patients with an anterior chamber depth of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens; and for patients with a stable refractive history (within 0.5 D for 1 year prior to implantation).