Staar Surgical announced that the FDA has granted approval of the PMA supplement for the Visian Toric ICL for the correction of myopia with astigmatism.
This approval represents an expansion of the Implantable Collamer Lens (ICL) product line for the correction of refractive error in patients with both myopia and astigmatism.
“Our toric lens can treat a much larger range of astigmatism—up to 4 diopters—with a single procedure, significantly benefiting the patient,” Caren Mason, President & CEO of Staar Surgical, said in an interview with Eyewire News. “Previously, the non-toric Visian Spheric ICL could be managed to treat up to 2.5 diopters, but this was accomplished through a procedure called bioptics where a second refractive method, such as corneal incisions, PRK, or LASIK was used. All of our Visian ICL lenses provide a host of advantages for patients, including UV protection, benefits for patients with thin corneas or dry eyes, and all without removing corneal tissue or the natural crystalline lens.”
The ICL in both spherical and toric designs has been associated with significant improvements in quality of life, Ms. Mason said. The approval of the Visian Toric ICL is an important step towards the future availability of advanced ICL models in the United States, such as the EVO/EVO+ Toric ICL.
Staar Surgical plans to make the Visian Toric ICL available to US surgeons on November 1, 2018.
The Visian Toric ICL is indicated for use in patients 21-45 years of age:
-for the correction of myopic astigmatism with spherical equivalent ranging from -3.0 D to ≤ -15.0 D (in the spectacle plane) with cylinder (spectacle plane) of 1.0 D to 4.0 D in the spectacle plane.
-for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0 D to -20.0 D (in the spectacle plane) with cylinder (spectacle plane) 1.0 D to 4.0 D in the spectacle plane.
-with an anterior chamber depth (ACD) of 3.00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation).
– The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.