Dr. Paul Doughtery carefully makes a 3-millimeter slit near the edge of the cornea of Rod Barshook's right eye and slides a rolled-up contact lens between the iris and the eye's own lens. After the lens unrolls itself, he gently tucks the edges under the iris. A few minutes later another contact is implanted in the other eye.
Less than a half hour later, Barshook sits in a reclining chair at Doughtery's Larchmont Village medical offices; his eyes are still a little blurry from the local anesthetic but he is able to read the clock on the opposite wall without the Coke bottle glasses he's worn most of his life.
"I'm pretty excited," he exclaims about the lens, manufactured by Monrovia-based Staar Surgical Co.
It's that "wow factor," as well as positive word-of-mouth and the enthusiasm of ophthalmologists like Doughtery, that Staar is counting on as the cornerstones of the marketing plan for its long-awaited, Visian ICL implantable contact lens.
"I knew this lens was the future," said Doughtery, who has been working with the lens since 1999 when he and handful of other surgeons traveled to Mexico to perform implantations as part of their training. "I knew the limitations of Lasik for people with higher levels of myopia. The further you push Lasik, the less accurate it is. We needed an alternative."
It's been slightly more than three months since U.S. regulators finally approved the ICL, which was already available in 41 other countries. Only a fraction of the U.S. surgeons who have received initial training are now certified to implant the device, and even those who can are only now beginning to receive brochures to distribute to patients.
The small Monrovia-based company employs only seven proctors to oversee the five monitored operations that surgeons have to perform before the company will supply them the lens. The company expects to have only 500 of nearly 1,000 eligible surgeons certified by the end of the year. But management believes the roll-out is going just fine.
"It sounds like a crazy situation but it's not really," said Chief Executive David Bailey, who followed a similar strategy when introducing Lasik eye surgery in Europe for another company in the mid-1990s. "A slow, steady ramp-up gives you solid outcomes and happy patients from which you can build the marketing. It's worth it to us in the long run to wait."
The Visian ICL is the first implantable lens for the correction of adult nearsightedness that is foldable, and therefore minimally invasive. It requires an incision about half the size of an older, competing lens marketed by Santa Ana-based Advanced Medical Optics Inc. Unlike refractive surgery, the procedure is reversible and significantly less prone to side-effects.
"Doctors are the best people to sell the technology and our role is to support that," said Bailey, noting that for the initial roll-out, surgeons with large refractive surgery practices have been targeted. "It's a very easy product to market because the word of mouth is so strong."
A consultant for Staar in addition to his medical practice, Doughtery now trains surgeons on the procedure and is involved in clinical trials to expand the lens' approved uses to also treat farsightedness. Since becoming involved with Staar, Doughtery now consults for other firms and venture capitalists.
"It's really been synergistic in building my business," said Doughtery, who studied at the Jules Stein Eye Institute at UCLA's Geffen School of Medicine and was one of the first U.S. surgeons to perform laser vision correction on an investigational basis before it was approved by the U.S. Food and Drug Administration in 1995.
"I have a good market advantage because I work with industry," he said. "This is a very high-tech industry, and patients want the latest thing. I don't jump on board every new technology, but I know I've gotten lucky with the ICL."
Pacific Growth Equities analyst Kate Sharadin found a similar level of excitement about the Staar lens when she questioned surgeons at a refractive surgery meeting in San Francisco last month. An early Sunday morning training session drew a standing room-only crowd of 350. "We think Starr has leaped over one its most difficult hurdles in turning the corner creating positive awareness," Sharadin said in an investor note.
Prospects were not always so bright for the company, which has reported losses in each of the last five years. Staar made its name in the early 1990s by marketing the first foldable intraocular lens (IOL) for cataract surgery. Outside the U.S., it began selling the ICL in 1996.
FDA approval came last December after for more than a year's delay over a variety of concerns, including problems at Staar's manufacturing plant in Monrovia. The ICL is made at a Swiss facility.
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