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Eyes of Wall Street on implant lens maker.


Whether blind as bats or merely squinters, people with less than 20/20 vision endure a lot to improve their view of the world. They fumble daily for glasses on nightstands, or frantically search bathrooms for a missing contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience. . They even permanently alter their corneas with laser surgery.

Now, Monrovia-based Staar Surgical Co. has developed an alternative - an implantable contact lens implantable contact lens Ophthalmology A refractive lens implanted over the natural lens of the eye for correcting myopia and farsightedness. See Myopia.  that can correct a broad range of nearsightedness nearsightedness or myopia, defect of vision in which far objects appear blurred but near objects are seen clearly. Because the eyeball is too long or the refractive power of the eye's lens is too strong, the image is focused in front of the  and farsightedness.

The solution is considered revolutionary by ophthalmologists, securities analysts and industry officials, but may not sound attractive to the squeamish squea·mish  
adj.
1.
a. Easily nauseated or sickened.

b. Nauseated.

2. Easily shocked or disgusted.

3. Excessively fastidious or scrupulous.
. An ophthalmologic surgeon makes a two-millimeter incision on the side of the eye. A corrective lens is then slipped in behind the iris and in front of the human lens, with the help of a tiny plunger. The eye seals itself, so no sutures are required to close the incision.

The outpatient procedure can take as little as five minutes and only requires a topical anesthesia Topical Anesthesia Definition

Topical anesthesia is a condition of temporary numbness caused by applying a substance directly to a surface of the body. Loss of feeling occurs in the specific areas touched by the anesthetic substance.
. The results are immediate, the surgery is imperceptible, and the lenses will not deteriorate over the years. If needed, however, a lens can be replaced with a different prescription down the road.

Dr. I. Howard Fine, a clinical associate of ophthalmology for the Oregon Health Sciences University, is one of the surgeons participating in the clinical trial on Staar's implantable contact lenses, or ICLs, which are underway in the United States. He believes the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 will approve the ICLs for sale on the mass market as early as next year.

"I have no doubt that an ICL (International Computers Ltd., London) The former name of Fujitsu Services, the European-centered arm of the global Fujitsu Group and one of the leading IT services companies in Europe, the Middle East and Africa.  is the best (means) to correct vision, and I have to say, the results are spectacular," Fine said. "The accuracy of the correction is unparalleled, since the effectiveness of laser refractive surgery Refractive surgery
A surgical procedure that corrects visual defects.

Mentioned in: Photorefractive Keratectomy and Laser-Assisted In-Situ Keratomileusis

refractive surgery 
 depends on how the cornea cornea: see eye.  heals. Every patient I've had so far has been very, very happy."

Staar's ICLs entered FDA Phase I limited trials in March 1997, and moved quickly to Phase II clinical trials in November. ICLs are undergoing trials in Canada, and they are already being sold and implanted in Europe, South America and Asia. The lenses have been available overseas since 1997.

John Wolf, Staar Surgical's chairman and chief executive, said the implantable contact lens was developed by Svyatoslav Fyodarov, known as the "father of radial keratotomy Radial Keratotomy Definition

Radial keratotomy (RK) is a type of eye surgery used to correct myopia (nearsightedness). It works by changing the shape of the cornea-the transparent part of the eye that covers the iris and the pupil.
" (the laser surgery used to correct vision). Fyodarov was developing an implantable contact lens procedure at his Moscow eye clinic. Wolf and a Staar team headed to Russia in early 1993 to sign a deal with the Russian ophthalmologist ophthalmologist /oph·thal·mol·o·gist/ (of?thal-mol´ah-jist) a physician who specializes in ophthalmology.

oph·thal·mol·o·gist
n.
A physician who specializes in ophthalmology.
. Staar now has an exclusive, worldwide license to manufacture and sell the lenses.

The biggest advancement is the bio-compatible material from which Staar's ICL is made. Lenses could not previously be implanted behind the iris because introducing foreign material into this part of the eye typically causes a cataract. Staar's R&D team developed a collagen-based material that the eye readily accepts. The lenses even absorb ultraviolet rays, so "you won't need to wear sunglasses," Wolf said.

Staar's other breakthrough is in the lenses' ability to be compressed to a fraction of their size without being damaged, allowing them to be slipped through the two-millimeter incision.

The company holds exclusive patents on all these breakthroughs.

Wolf said that one man in the study was so satisfied with the ICL in his one eye (all that the FDA would permit at that stage of the trial) that he left the country to have a foreign surgeon implant an ICL in his other eye.

"Once this technology gets approval, it can revolutionize the eye care industry," said Deborah Lowenthal, an analyst at Red Chip Review, a small-cap stock research firm. "We expect ICLs to be hugely popular."

Staar executives are excited about the sheer potential of the market for ICLs.

"In the U.S. alone there are 77 million myopic and 55 million hyperopics (farsighted far·sight·ed or far-sight·ed
adj.
1. Able to see distant objects better than objects at close range; hyperopic.

2. Capable of seeing to a great distance.
 people)," Wolf said. "The world market is substantially larger."

Cruttenden Roth Inc. released a report that estimates the annual foreign market for ICLs alone to eventually reach $1.5 billion. Staar's ICL sales in foreign markets have risen in each of the five quarters since they were launched, reaching $600,000 in the quarter ended April 3, up 50 percent from the previous quarter.

Even more auspicious for Staar is that its ICLs face no direct competition. The relatively popular radial keratotomies and other procedures that use lasers to permanently reshape corneas and thereby improve vision are only effective on limited problems, industry experts said.

"The various laser procedures cannot correct the wide range of (nearsightedness) that ICLs can, nor can they really correct (farsightedness) to any sort of significant degree," Fine said. "All the surgeons I know are pleased with what ICLs can address."

An ICL procedure does carry some risks, including eye infection, a cataract, or corneal corneal

pertaining to the cornea. See also keratitis, keratopathy.


corneal anomaly
includes microcornea, coloboma, megalocornea, dermoid, congenital opacity.

corneal black body
see corneal sequestrum (below).
 changes. "Complications have been extremely rare in the study, and they are all readily addressable," he said, "but surgery is always a risk."
COPYRIGHT 1998 CBJ, L.P.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:Staar Surgical Co.
Author:Fisher, Sara
Publication:Los Angeles Business Journal
Date:Jun 8, 1998
Words:822
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