ICL- Implantable Contact Lenses Information Guide

The Staar Surgical Company, based in Monrovia, CA, is a manufacturer of vision enhancement products. One of their products is currently in the news for its dramatic rise in popularity - the Visian ICL (Implantable Collamer Lens). The only other company producing ICL lenses is Verisyse lens, however Visian ICL is already the leader in the market with their innovative technology. In short, STAAR Surgical company is essentially banking on the success of the Visian to provide it with the financial muscle to make STAAR a more formidable competitor in the overall marketplace for a variety of ophthalmic devices and instruments.

The Visian ICL is a contact lens which can be implanted to correct the eye’s refractive error, and is an alternative treatment to LASIK. The best news that STAAR had received in years occurred in December, 2005 when the FDA approved the Visian for the treatment of myopia in adults 21 to 45 with corrections ranging from -3 D to -20 D, with astigmatism less than or equal to 2.5 D at the spectacle plane, anterior chamber depth 3 mm or greater, and a stable refractive history within 0.5 D for a year prior to implantation. It was given FDA approval in . Of the 1.4 million LASIK procedures that are performed annually in the U.S., the Visian ICL has so far captured less than one percent. But this gives it a lot of room to grow, and there is not a lot of competition.

Staar’s shares have increased 72% in Nasdaq trading so far this year. Analysts are expecting sales this year of $80.7 million, and $90.5 million next year. That would bring it close to $100 million, at which point a larger company would probably want to buy it. The Visian ICL’s technology is ingenious, making it an excellent product, and a company like Bausch & Lomb or Johnson & Johnson would likely want to acquire it.

LASIK procedures have recently slowed down in numbers. However, ICL surgeries increased about 50% during 2007.

1. The ICL is a reversible procedure, so that if your eyes change over the years, the ICLs can be replaced to match. They are made of collamer, a pure collagen copolymer which the body will not reject.
2. You would not feel or see the ICLs within your eyes
3. Your visual clarity would be vastly improved, as well as your vision quality — no halos around lights, starbursts in low light conditions, etc.
4. Others would not be able to detect the presence of the ICLs in your eyes
5. Based on 55,000 eyes worldwide, the ICLs have an excellent safety record.

STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced that a surgical implantation of its VISIAN ICL will be featured tomorrow, Friday August 8th on the CBS Television Network “Early Show.” The CBS “Early Show” has focused all week on a series the show has called “Medical Miracles” and tomorrow’s segment will be the final one in the series. This segment shows an unusual procedure in which Dr. Paul Dougherty of Los Angeles uses the lens to treat a seven-year-old girl at risk of visual loss in one eye because of amblyopia, a condition sometimes called “lazy eye.”

The VISIAN ICL is a tiny, foldable implantable lens that has been approved by the FDA for the correction of myopia, or nearsightedness, in adults aged 21 to 45. The VISIAN ICL is not approved for the treatment of amblyopia; however, studies published in peer-reviewed medical journals have explored the use of refractive surgery, including implantation of the VISIAN ICL, for hard-to-treat amblyopic children.

“Because of the superb vision quality it delivers, an increasing number of my adult patients with myopia are now choosing the VISIAN ICL to correct their vision,” Dr. Dougherty noted. “The procedure does not remove tissue or reshape the eye. So while the lens is designed to remain in the eye permanently, an appealing feature for many of these patients is the fact that it can be removed if the patient’s vision changes or for any other reason, which keeps future treatment options open.”

The VISIAN ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from -3.0 to less than or equal to -15.0 diopters, with astigmatism less than or equal to 2.5 diopters at the spectacle plane, and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.

STAAR is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR’s products are used by ophthalmic surgeons and include the VISIAN ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. The ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 40 countries.

Dr. Paul Dougherty delicately slipped a tiny lens inside the right eye of 7-year-old Megan Garvin — a last-ditch shot at saving her sight in that eye.

The California girl last week became one of a small number of U.S. children to try an experimental surgery to prevent virtual blindness from lazy eye diagnosed too late, or too severe, for standard treatment. The new approach: Implantable contact lenses, the same kind that nearsighted adults can have inserted for crisper vision — but that aren’t officially approved for use in children.

Up to 5 percent of children have amblyopia, commonly called lazy eye, where one eye is so much stronger than the other that the brain learns to ignore the weaker eye. Untreated, the proper neural connections for vision don’t form, eventually rendering that eye useless.

Catch it early — preferably by preschool — and it can be fairly easy to fix by patching over the strong eye, or using special drops in it, for several hours a day so that the brain is forced to use the weak eye. But the older the child is, the less effective the treatment — and by age 9, brain-eye connections are pretty well set.

It’s sneaky: Kids don’t realize they’re seeing clearly out of only one eye, and often won’t squint or otherwise signal there’s a problem. So Megan was fast passing the window to correct amblyopia when a kindergarten eye exam flagged a problem.

“She reads perfectly, she’s a very normal active child,” says her mother, Rosie Garvin. “If she would not have had that vision test, I would never have known.”

Ophthalmologists called it one of the worst cases they’d ever seen. Glasses weren’t doable: One side would have required a clear lens and the other a Coke-bottle thickness, a prescription of minus 12 diopters. Her parents tried inserting a contact lens in the bad eye — getting her to roughly 20-60 vision in that eye, far from perfect but able to see blurrily while the good eye was patched.
Implantable lenses for adults, called phakic intraocular lenses or IOLs, hit the U.S. market in 2004. Unlike cataract surgery that requires removal of the eye’s natural lens because it is clouded, these lenses are put on top of a natural lens that can’t focus properly, thus helping sharpen vision.

They have some risks: Surgical infection, inflammation, a potential for cataracts to form. At about $4,000 an eye, it’s more expensive than the controversial laser eye surgery LASIK, but the lenses can be removed if there are problems.

But, “how this lens is going to work in a child’s eye, we don’t know. We’ve never done studies,” cautions Dr. Punin Shah, a cornea specialist at Ochsner Medical Center in New Orleans.

It is legal to implant the lenses experimentally in a child, however. A handful of medical journal reports show surgeons are starting to try the approach for hard-to-treat amblyopia. In a French study of a dozen children, all had improved vision after the surgery and half recovered normal binocular vision.

Other surgeons are experimenting with LASIK in children like Megan, although she wasn’t a LASIK candidate — her corneas were too thin for it to be done safely, and Dougherty says it doesn’t work well for such severe nearsightedness.

Dr. Michael Repka, a pediatric ophthalmologist at Baltimore’s Johns Hopkins University, says both approaches are in their infancy, but interesting.

“It’s an exciting thing in a patient who has had conventional therapy and failed,” says Repka, a spokesman for the American Academy of Ophthalmology.

And while catching lazy eye very young is best, stay tuned: Repka’s own research shows it can be possible to treat after age 9, long the cut-off, and he is to publish details soon.