STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced CE Mark approval for a range of product improvements to the Company's Visian Implantable Collamer® Lens (ICL™) that more than doubles the current Visian addressable market in Europe. Included in the approval, STAAR Surgical received CE Mark approval for a Hyperopic Toric ICL which is designed for patients with both hyperopia, as well as astigmatism. Patients with hyperopia often referred to as farsightedness; have difficulty focusing on objects that are close up. Astigmatism is usually caused by an irregularly shaped cornea that causes blurred vision. Such patients are beyond the effective reach of existing surgical technologies and the Visian is the only option which will allow for the treatment of both conditions with one procedure.
"We believe these expanded offerings will provide the broadest correction approval of any refractive technology for surgeons in countries where the CE Mark applies and will allow the surgeon to treat virtually any patient who is a candidate for refractive surgery," said STAAR Surgical CEO Barry G. Caldwell. "This approval will now allow surgeons to treat myopic patents from -0.5D to -2.75D with the new Visian ICL, hyperopic patients from +0.5D to +2.75D with the new Hyperopic ICL and both myopic and hyperopic astigmatic patients with up to 6 diopters of astigmatism. The addition of quarter diopter increments for low myopes (-0.5D to -2.75D) and low hyperopes (+0.5D to +2.75D) should optimize refractive targeting the sweet spot of the LASIK range and allow the surgeon to deliver an even more customized solution. STAAR is committed to the continuous improvement and expansion of patient benefits offered by the Visian ICL product line and additional Visian ICL features are in our pipeline. Our goal is to continue to offer new technology benefits in order to maintain the Visian ICL's leadership role in the refractive lens market."
With the CE Mark approval STAAR Surgical now offers Visian ICLs in the applicable countries ranging from myopic ICLs at -18.0D to hyperopic ICLs at +10.0D without interruption. Additionally STAAR can offer Visian Toric ICLs up to 6.0 diopters of cylinder for the entire range. For diopter ranges between -3.0D and +3.0D, the CE Mark approval has been expanded to quarterly increments from the previous 0.5 increments. Specifically, diopter range of ICL models will be extended to now cover the following diopters:
- Positive spheric, 0.25D increments from +0.5D to +2.75D, 0.5D increments from +3.0D to +10.0D.
- Negative spheric, 0.25D increments from -0.5D to -2.75D, 0.5D increments from -3.0D to -18.0D.
- Toric addition, 0.5D increments from +0.5D to +6.0D for all diopters from -18.0D to +10.0D, excluding quarter diopters, including 0.0D.
In addition to the expanded diopter range and Hyperopic Toric CE Mark approval, STAAR Surgical also designed several enhancements that increase physician ease of use of the Visian ICL during implant. These improvements include: the addition of perforating holes in the lens haptic to assist with removal of viscoelastics, improved lubricity on injector cartridges for ease of insertion, and new laser marks for the TICL designed to improve the surgeon's ability to see the axis during and after implantation.
"We've also been approved to begin packaging Visian ICL products for CE markets in BSS, Balanced Salt Solution, which is the same storage medium for product marketed in the U.S. We will also be submitting data to improve the current two-year shelf life to five years. These approvals are the first step toward allowing us to move our global refractive business to a unified platform that should lead to greater manufacturing efficiencies," added Mr. Caldwell.
STAAR Surgical first received CE Marking for the ICL in 1997, indicating the product is approved by the European Union (EU) and by other countries that recognize the CE Mark.
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