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STAAR Surgical's VISIAN ICL(TM) Receives FDA Approval

MONROVIA, CA -- December 23, 2005 -- STAAR Surgical Company reported that the U.S. Food and Drug Administration (FDA) has approved the Company's Myopic VISIAN ICL(TM) for use in the correction of myopia in adults.

Made of STAAR's proprietary, highly biocompatible Collamer(R) material, the ICL (Implantable Collamer Lens) is the only minimally invasive foldable lens of its kind approved for the U.S. commercial market. As a result of the unique foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome. In addition to the U.S., the ICL is also approved for sale in 41 countries, including the European Union and has successfully been implanted in more than 40,000 eyes worldwide.

The Company expects to begin shipping the VISIAN ICL to trained doctors in six to eight weeks. In addition, STAAR plans to showcase the new product through training courses and other educational sessions at key upcoming industry symposia including the Royal Hawaiian Eye Meeting and the American Society of Cataract and Refractive Surgery meeting.

"The ICL remains our most significant opportunity for profitable growth going forward and receipt of FDA approval represents a critical milestone," said David Bailey, President and CEO of STAAR Surgical. "Throughout the approval process, doctors' interest in our state-of-the-art lens has continued to build, driven by superior clinical outcomes, the stability and safety of the procedure and the high patient satisfaction rate. We believe the ICL offers patients and their doctors opportunities to achieve higher quality visual outcomes compared with competing technology and this characteristic will be an important growth driver of the refractive phakic implant market. Based upon these dynamics and the success of the ICL in the international markets, we believe that we are well positioned to begin building a strong franchise in the U.S.

"We continue to plan for a controlled commercial launch and believe that the investments we made in our marketing programs two years ago have allowed us to build the infrastructure necessary to be successful," continued Mr. Bailey. "As we have done internationally, we will guide doctors through our training and certification process, which includes proctoring the first five surgeries. Currently, we have more than 860 surgeons who have completed the first phase of training and are ready to be proctored by the five application specialists that we have on staff. Once the doctors have successfully completed the surgeries, they will become certified and will be eligible to order additional VISIAN ICL lenses without a proctor. We believe that this process, which focuses on correct technique, will support high quality clinical outcomes and better ensure proper use of the lens."

The VISIAN ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from -3.0 to less than or equal to -15.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.


SOURCE: STAAR Surgical Company

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