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. They even permanently alter their corneas with laser surgery.
Now, Monrovia-based Staar Surgical Co. has developed an alternative an implantable contact lens that can correct a broad range of nearsightedness and farsightedness.
The solution is considered revolutionary by ophthalmologists, securities analysts and industry officials, but may not sound attractive to the squeamish. 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. 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 currently underway in the United States. He believes the FDA will approve the ICLs for sale on the mass market as early as next year.
"I have no doubt that an ICL 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 depends on how the cornea heals. Every patient I've had so far has been very, very happy."
Staar's ICLs entered FDA Phase 1 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" (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. Staar now has an exclusive, worldwide license to manufacture and sell the lenses.
"We took the original concept and have put a lot of our own R & D; into it to better develop the process," Wolf said. "The design is sophisticated to the point that it is the eye equivalent of arthroscopic surgery on a knee."
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 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 changes. "Complications have been extremely rare in the study, and they are all readily addressable," he said, "but surgery is always a risk."
Meanwhile, Wolf sounds like a CEO sitting on top of a gold mine.
"From the standpoint of our company, Staar can become a $150 million company in five years," he said. "We have exclusive patents for ICLs as well as a couple other new ophthalmologic devices in a major world market. And when we get approval, the gross margins on the products are very good."
Lowenthal agreed that the product margins are "enormous," but cautioned that the growth would not be immediate. She said competitive pricing in the cataract lens market, Staar's core business, has driven down earnings and stock price recently. Staar's 1997 net income of $7.4 million compares with $6.9 million a year earlier.
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