Evo Visian Implantable Collamer Lenses (ICL) can now extend to patients between the ages of 21 and 60 years old. Its previous indication covered patients between 21 and 45. The expanded approval comes on the heels of three-year clinical data that reinforces the long-term safety profile of EVO ICL.
Lake Forest, California-based Staar says the expansion helps further increase the addressable market for EVO in the U.S.
EVO ICL preserves corneal tissue and the eye’s natural crystalline lens. It offers a reversible, lens-based approach to vision correction that maintains future treatment flexibility. The company designed it to support long-term vision care and allow surgeons to tailor future solutions as needs evolve over time.
Lens implantation takes place in a quick, minimally invasive procedure. Surgeons position the EVO lenses behind the iris and in front of the natural crystalline lens.
Staar Surgical says that approval comes as EVO ICL implantations continue to grow in the U.S. as well. It says trends indicate that laser-based refractive procedures are declining significantly, while alternatives to LASIK continue to grow.
This significant milestone for Staar comes not long after a big shift at the company. Following a successful effort by shareholders to block an acquisition by Alcon, the company’s chair and CEO both stepped down amid a leadership shuffle in the fallout.
“When experienced surgeons consistently favor a lens-based approach for high myopia, it reflects a clear shift in treatment patterns,” said Warren Foust, interim co-CEO, president and COO of Staar Surgical. “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.”
