The FDA has granted approval to STAAR Surgical Company for an expanded age indication for EVO / EVO+ Visian Implantable Collamer Lenses (ICLs).
Let’s start with a look at ICLs.
STAAR’s line of ICLs—which, take note, are also phakic intraocular lenses (IOLs)—were first introduced in March 2022 with the FDA approval of:
- EVO ICL
- For myopia and astigmatism; indicated for patients aged 21-45
- EVO+ ICL
- For myopia and astigmatism with an expanded optic; indicated for patients aged 21-45
- Visian ICL
- For myopia, hyperopia, and astigmatism; indicated for patients aged 21-45
Next: Their purpose and design.
Each artificial, implantable lens is designed to address a wide range of vision correction needs via a reversible, minimally-invasive refractive procedure requiring no corneal tissue removal.
The lens itself: Is a “collamer” composition consisting of a patented, biocompatible, and FDA-approved lens material involving a polymer and collagen blend.
Can you get specific on this blend?
More specifically, these phakic IOLs are made from:
- 60% poly-hydroxymethylmethracrylate (HEMA)
- 36% water
- 3.8% benzophenone
- 0.2% porcine collagen
The resulting effect: A lighter and hydrophilic lens intended to enable a better exchange of gas and nutrients, featuring a “rectangular one-piece plate-haptic design lens” that’s also plano-concave.
And when implanted?
Via this corneal tissue preservation—as well as the eye’s natural crystalline lens—EVO ICL “offers a reversible, lens-based approach to vision correction that maintains future treatment flexibility.”
Alrighty, now to the FDA’s approval.
In an effort to serve a broader (and global) patient population, the federal agency has approved STAAR’s request to expand the ICLs’ age range from 21 to 45 to now 21 to 60.
So what’s the entire updated indication for this ICL?
The EVO Visian ICL is now indicated for use in phakic eye treatment among patients aged 21 to 60:
- For myopia correction / reduction in patients with spherical equivalent (SE) ranging from -3.0 D to -20.0 D at the spectacle plane
- For myopia astigmatism correction / reduction in patients with SE ranging from -3.0 D to -20.0 D with cylinder of 1.0 D to 4.0 D at the spectacle plane
- 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
- With a stable refractive history (within 0.5 D for 1 year prior to implantation
Any clinical data worth noting?
STAAR referenced long-term (3-year) safety data from an FDA clinical study (NCT04283149) involving 629 eyes that were followed for 3 years following EVO ICL implantation.
- See here for the study setup and outcomes.
The findings: The ICL was reported to demonstrate a “strong safety profile with a safety index of 1.25 at 3 years,” along with:
- No reported cases of pupillary block or pigment dispersion
- A low incidence of anterior subcapsular cataract (0.16%)
Any other research?
Outside the U.S., a retrospective study on the ICL was conducted by the American-European Congress of Ophthalmic Surgery (AECOS) and sponsored by STAAR.
- Conducted at 19 clinical locations, this was designed to analyze how age, refractive error, and anatomical characteristics determined the choice of refractive procedure
According to Warren Foust, newly-appointed STAAR interim co-CEO, president, and chief operating officer: “EVO ICL accounted for more than 70% of procedures in patients with -8.0 diopters and above.”
And what’s the significance of this?
Foust noted that the data offers a “real-world snapshot of where refractive surgery is heading in the U.S.,” with the EVO ICL helping to “define the future pathway for treating a broad range of myopia.”