BW1013 MAR 25,1998 3:32 PACIFIC 06:32 EASTERN
( BW)(STAAR-SURGICAL)(STAA) STAAR Surgical Receives
FDA Approval to Begin Phase II Clinical Trials for Its
Implantable Contact Lens for Farsightedness
Business Editors/Health & Medical Writers
MONROVIA, Calif.--(BW HealthWire)--March 25, 1997--
Procedure for Hyperopia Offers Hope Where No Other Surgical
Remedy Exists
STAAR Surgical Company (NASDAQ:STAA) today announced that the
Food and Drug Administration (FDA) has released the Company to begin
Phase II of its clinical trials for the revolutionary Implantable Contact
Lens(tm) (ICL(tm)) to correct farsightedness (hyperopia). The FDA's
release will allow STAAR to implant 62 ICLs in patients and to increase its
investigator base from 4 to 10 surgeons.
"The results from Phase I trials and from ongoing international clinical
trials that we presented to the FDA were even better than our Phase I
myopia results," said John Wolf, chairman and president of STAAR
Surgical. "The success of all of our work to date is a direct result of the
strength of STAAR's technology, the skills of the surgeons involved, and the
clinical data that has been obtained in the U.S. and internationally."
All ten patients included in the Phase I trials had preoperative hyperopia,
or farsightedness, between 2.5 and 11.0 diopters, covering a wide range of
hyperopia. Average preoperative hyperopia was 6.05 diopters. At last visit,
seven of the ten participants were seeing 20/20 or better without spectacles
or contact lenses in the eye treated with the ICL, and all were seeing 20/40
or better.
All treated eyes had 20/30 or better vision with glasses or contacts, and 9
of the 10 eyes could see 20/20 or better with correction. No patient
experienced a decrease in best corrected vision, and two of the patients
actually experienced an improvement in their best corrected vision. This is
important, as decreases in best corrected vision have been reported with
other refractive procedures, such as lasers. Eight of ten cases were within
0.5 diopters of perfect correction after the surgery and all were within 1.5
diopters of perfect correction. Furthermore, no operative or postoperative
complications or adverse reactions were observed in any of the patients.
"Worldwide, surgeons now have implanted more than 3,000 ICLs. The
Phase I outcome for hyperopia is very consistent with the positive data we
have received from doctors around the world, many of whom have done
numerous ICL surgeries," Wolf continued. "What makes this really exciting
is that it offers hope to patients with hyperopia for whom no other surgical
remedies exist and for whom glasses are often completely inadequate for
obtaining good vision.
"We are also very excited about the Phase II myopia study, where we
continue to see good visual results. Now that patient enrollment for Phase II
of the myopia study is complete, we are hopeful we can get approval from
FDA to expand that study to Phase III as soon as possible."
STAAR's ICL is used to correct nearsightedness and farsightedness, the
two most common eyesight problems. The ICL is placed in the eye in a
matter of minutes in a suture-less and virtually painless outpatient
procedure. In 1996, STAAR began marketing the ICL in South America,
South Africa, the Middle East, China and certain European countries. In July
1997, the Company announced that it had received the European CE Mark
of approval for several of its products, including the ICL, which allows
STAAR to freely distribute these products in all European Union countries.
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 the foldable
intraocular lenses, which are used as replacements for the natural lens in
cataract procedures. In addition to the ICL, STAAR also markets, in select
foreign countries, two new products: a "wick" style glaucoma implant for
the treatment of glaucoma and STAARVISC, a viscoelastic used in both ICL
and IOL surgery. The FDA has approved U.S. clinical trials of the glaucoma
wick.
For additional information, visit the Company's web site at
staar.com.
Anyone interested in enrolling in STAAR's Phase II hyperopia trials
should contact Dr. Donald Sanders at 630/530-9700, ext 12 or Mr. Steve
Ziemba at 626/303-7902 for the name of the nearest participating surgeon.
--30--ik/sf* ms/sf
CONTACT: Staar Surgical Company
William Huddleston, 626/303-7902
or
Morgen-Walke Associates, Inc.
John Swenson, Elizabeth Snowdon, Doug Sherk (Investor
Relations) or
Sheryl Seapy, Carol Lehrman (Media Relations)
415/296-7383
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: MEDICINE BIOTECHNOLOGY PRODUCT |
