MONROVIA, Calif., Apr. 28, 2006 /PRNewswire-FirstCall/ -- STAAR Surgical
Company (Nasdaq: STAA - News) today announced that it has submitted
a Pre-Market Approval (PMA) supplement to the U.S. Food and Drug
Administration (FDA) for its Visian TICL, a toric implantable Collamer®
lens designed to treat both nearsightedness and astigmatism.
STAAR submitted the Visian TICL application as a supplement to
the PMA for its Myopic Visian ICL(TM), which the FDA approved on
December 22, 2005 for use in correction of myopia in adults and
which is now available to patients in the U.S. The review time period
for a PMA supplement is typically 180 days from the date of submission
to the FDA.
The Visian TICL supplemental filing supports an indication for
use in adults 21 to 45 years of age for the correction of myopia
ranging from -3.0 to -20 diopters with astigmatism of 1 to 4 diopters.
Astigmatism, which is usually caused by uneven curvature of the
surface of the eye, causes light rays to focus at different points
inside the eye. A person with astigmatism will experience blurriness
in part of the visual field in both near and distance vision.
Made of STAAR's proprietary, highly biocompatible Collamer material,
the Visian ICL is the only minimally invasive, foldable lens of
its kind approved for the U.S. commercial market, and its placement
in the eye behind the iris provides a more aesthetically pleasing
outcome than competing refractive implants. The Visian TICL shares
the same unique, foldable design, and like the Visian ICL, it is
implanted through a small incision, approximately 3 mm. The difference
in the Visian TICL is its toric optical design, which permits the
doctor to correct both spherical and cylinder refractive conditions
in a single, quick procedure.
"We are very pleased to submit our supplemental PMA for the Visian
TICL," said David Bailey, President and CEO of STAAR Surgical. "The
submitted data indicates very positive surgical outcomes, in fact,
98% of all patients reported that they were 'very' or 'extremely'
happy with the surgical results and no patients were dissatisfied.
The Visian line remains our most significant opportunity for profitable
growth in the future and our submission of the TICL PMA supplement
is another important milestone toward executing our long-term strategy.
If approved, the TICL will be the only phakic implantable lens product
available in the U.S. to treat myopia and astigmatism. Based on
the interest we have seen in international markets where the TICL
is already approved, we believe our product can uniquely serve the
growing needs of the dynamic refractive market in the U.S."
The Visian TICL is a refractive phakic implant intended for placement
in the posterior chamber of the eye. The supplemental filing supports
an indication for the correction of myopia in adults with myopia
ranging from -3.0 to less than or equal to -20.0 diopters with astigmatism
ranging from 1 diopters to 4 diopters at the spectacle plane, 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.
