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( BW)(STAAR-SURGICAL)(STAA) STAAR Surgical Company's
Innovative Glaucoma Wick to Begin FDA Clinical Trials
Business Editors & Health/Medical Writers
MONROVIA, Calif.--(BW Healthwire)--Nov. 7, 1997--STAAR Surgical Company
(NASDAQ:STAA) today announced that the U.S. Food and Drug Administration (FDA) has
approved STAAR to begin human clinical trials in the United States on the STAAR Glaucoma
Wick(TM), a unique implantable device used in the long-term treatment of open-angle glaucoma,
a disease which affects more than 67 million people worldwide.
The study, to be conducted under an Investigational Device Exemption (IDE), will be
conducted at nine clinical centers throughout the United States, including some university-based
glaucoma clinics and some private medical practices.
Approximately 175 patients with open-angle glaucoma, the most common form of the disease,
will be enrolled in a single phase study and followed for one year, after which STAAR plans to
submit the data to the FDA for marketing clearance of the Wick.
STAAR's Glaucoma Wick is designed to provide patients with open-angle glaucoma with
immediate and long-term relief from the high intraocular pressure commonly associated with their
condition. Made from a proprietary, collagen-based material developed by STAAR, the Wick is
surgically implanted in the eye in a non-penetrating out-patient procedure that is typically
performed in about 30 minutes.
By facilitating fluid drainage in the eye, the Wick gives patients an immediate reduction in their
intraocular pressure. The device dissolves several months after it is implanted, leaving behind
porous tissue that allows for continued fluid drainage over a period of several years. Because the
surgical implant procedure does not penetrate the eye, complications during and following the
surgery are rare and relatively minor.
John Wolf, President and CEO of STAAR, stated, "Receiving an IDE for our Glaucoma Wick
is a major milestone for STAAR. All existing glaucoma drainage devices are basically ineffective,
so surgeons are reluctant to use them. The current surgical standard, trabeculectomy, involves a
penetrating incision made inside the eye to remove clogged drainage tissue and can result in
severe complications.
"Moreover, because the reduction of pressure in the eye frequently is transient with
trabeculectomy, patients are often forced to undergo repeated surgeries. Many physicians
therefore prefer to treat glaucoma with medications, yet this approach is extremely costly, has
various side effects and is compromised if patients do not follow the complicated drug regimens.
"We believe the Wick will become the glaucoma treatment of choice for surgeons because it is
comparatively cheap, reliable, results in few complications and requires minimum patient
maintenance."
Wolf continued, "The safety and reliability of the Wick has been demonstrated in Europe,
where we have been implanting the device in trials for the past several years and recently
received the CE Mark of approval to market it throughout the European Union.
"The superior results from these overseas procedures indicate to us that the Wick is an ideal
cost-effective solution for managed care providers. Instead of paying for multiple ineffective
surgeries or prolonged drug treatment regimens that can easily cost more than $2,000 annually,
managed care providers will now have a safe, effective and less expensive long-term alternative
for glaucoma treatment."
Glaucoma affects roughly 67 million people worldwide and is a leading cause of blindness if
left untreated. Each year, roughly 300,000 people in the U.S. alone undergo surgery to treat
glaucoma. Altogether, the worldwide market for the treatment of glaucoma is approximately $1
billion annually, including $100 to $200 million in the surgery market and $850 million in the drug
market.
Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes
medical devices used in minimally invasive ophthalmic surgery. The company's principal product
line includes foldable intraocular lenses, which are used as replacements for the natural lens in
cataract procedures.
STAAR also markets, in foreign countries, two new products: a "wick" style glaucoma implant
for the treatment of glaucoma and the ICL(TM), a deformable intraocular refractive corrective
lens, for the treatment of near and farsightedness. All of the company's products have received
CE Marking for distribution in the European Union.
For additional information, visit the Company's new web site at staar.com . |
