STAAR Surgical said the US Food and Drug Administration (FDA) has approved the PMA Supplement for the Visian Toric ICL for the correction of myopia with astigmatism.
This 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 which are common conditions in the United States (US). Astigmatism affects approximately 30% of the population.
The ICL in both spherical and toric designs has been associated with significant improvements in quality of life. Patients have described ICL surgery as ‘life changing’ or wished they had opted for the surgery sooner.
The approval of the Visian Toric ICL is also an important step towards the future availability of advanced ICL models in the US, such as the EVO/EVO+ Toric ICL.
STAAR Surgical president and CEO Caren Mason said: “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.
“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 1 November, 2018.”
The Directions for Use (DFU) lists the indications as: 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 1 year prior to implantation).
- The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
Source: Company Press Release