It will be available starting Nov. 1.
MONROVIA, CA -- STAAR Surgical Co., a developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, announced that the U.S. Food and Drug Administration has granted approval for the Visian Toric ICL for the correction of myopia with astigmatism.
The approval "represents a meaningful expansion of the Implantable Collamer Lens (ICL) product line for the correction of refractive error in patients with both myopia and astigmatism," the company said in a press release.
The ICL in both spherical and toric designs has been associated with significant improvements in quality of life, according to the release. STAAR Surgical added that the approval of the Visian Toric ICL "is also an important step towards the future availability of advanced ICL models in the US."
"FDA’s approval of STAAR’s Visian Toric ICL in the U.S. provides an exciting treatment option for myopic patients with astigmatism in search of visual freedom," said Caren Mason, president and CEO of STAAR Surgical. "We are thrilled to be able to offer this lens in the United States and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients on November 1st, 2018."
The Visian TICL 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 one year prior to implantation).
The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
More than 900,000 Visian ICLs have been implanted to date, according to the release. STAAR has about 400 full-time equivalent employees and markets lenses in over 75 countries. Headquartered in Monrovia, CA, the company operates manufacturing facilities in Aliso Viejo, CA, and Monrovia.