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STAAR Sees Visian as Key to Success
Predictions on size of the phakic IOL market vary.
JERRY HELZNER, SENIOR EDITOR

This article will discuss the characteristics of the Visian, its performance history and the potential of the U.S. marketplace for phakic IOLs in general and the Visian specifically.

Hope Replaces Frustration

The best news that STAAR had received in years occurred shortly before last Christmas 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. Prior to that welcome news, STAAR had been beset by declining overall sales, a bottom line that showed losses, and a crippling manufacturing noncompliance issue in the company's Monrovia manufacturing facility that led to as much as an 18-month delay in approval of the Visian.

The delay that lasted until the Monrovia facility was brought into compliance with FDA standards cost STAAR the coveted "first mover" advantage in the race to get the first phakic IOL into the U.S. marketplace. Advanced Medical Optics (AMO, Santa Ana, Calif.) won approval for its Verisyse phakic IOL in September of 2004.

However, the Visian ICL differs greatly from the Verisyse in that it is a foldable posterior-chamber collagen co-polymer lens, while the Verisyse is an iris-clip PMMA lens. The Visian can be implanted in a sutureless procedure through a relatively small 2.8 mm incision while the Verisyse requires a 5.5 mm incision and suturing to be implanted. A next-generation foldable acrylic version of the Verisyse called the VeriFlex which requires only a 3.2 mm incision is now in clinical trials in the United States and could be approved by late next year.

In addition to the Visian ICL, STAAR is now ready to submit an application for FDA approval of a toric version, known as the Visian TICL. Because this is a supplemental application that will not have to go through a lengthy review process, approval could come as early as late 2006 or early 2007. The toric version is considered an important addition because it provides a simpler procedure for surgeons in dealing with astigmatism and eliminates the need for imprecise limbal relaxing incisions that can result in less satisfying outcomes.

Because of the major differences between the Visian and the Verisyse, it is almost impossible to use the Verisyse as a benchmark to predict how the Visian will be accepted in the marketplace. Initial acceptance of the Verisyse has been limited, with the respected industry newsletter MarketScope estimating that about 8,000 phakic IOLs were implanted in the United States in 2005.

Innovation Must Equal Execution

In its almost 25-year history, STAAR has earned a reputation as a technology innovator that often has difficulty in successfully executing its growth strategies against such powerful and well-financed competitors as Alcon, AMO and Bausch & Lomb. To provide just a basic comparison, Alcon generates about $4 billion in annual sales while spending about $400 million a year on research and development. STAAR had total sales of just over $51 million in 2005, or about one-eighth of what Alcon spends on R&D alone.

In the Visian, STAAR believes that it has a lens that provides excellent visual outcomes with low risk of complications in a procedure that can be reversed if necessary. The company views the market for the Visian as consisting of patients with severe myopia, along with other patients with myopia who may have dry eye, thin corneas or atypical corneal configurations. STAAR also emphasizes that the Visian can provide cataract surgeons a relatively easy transition of their existing skills into the more profitable arena of elective refractive surgery. Bilateral Visian implantation is expected to cost patients an average of $7,000 to $8,000.

Supporting the Launch

Because of the potential that it sees in the Visian ICL, STAAR is placing its full financial backing behind this launch, using the past 2 years to invest in a marketing infrastructure to support the Visian introduction.

"Execution is the key, says STAAR president and CEO David Bailey. "We are conducting a controlled, targeted rollout with excellent training and proctoring that is resulting in delighted patients and happy surgeons. I am very pleased with the way the rollout is progressing."

Bailey told Ophthalmology Management that the first group of doctors being targeted are those in relatively high-volume practices who have their own ASCs and who perform both LASIK and cataract surgery.

"These doctors see a number of patients who want vision correction but are not good candidates for LASIK," notes Bailey. "Many of these patients are going to be good candidates for the Visian. Also, these are practices with experience in marketing refractive procedures."

When asked if STAAR was going to also target traditional cataract surgeons who may not have experience with LASIK or with consumer marketing, a group that some have said would be perfect candidates to add the more profitable phakic IOLs to their practice, Bailey said "we will welcome them, too."

Bailey says that almost 1,000 surgeons have taken their phase 1 didactic training on the Visian. Eighty five are now fully certified after being successfully proctored through five implantations.

"We saw wonderful interest at the ASCRS meeting, with 350 doctors showing up for a CME course at 6 a.m. on a Sunday morning and more than 50 taking phase 1 training. Some may be surprised but I expected this kind of interest from surgeons."

Bailey will not discuss numbers on anticipated U.S. Visian procedure volume, but STAAR hopes that the Visian will eventually account for 40% of total company sales. It recently accounted for about 10% of overall sales, all of that coming from outside the United States. STAAR also believes that a successful Visian will jump-start sales of its other IOLs, especially the IOLs that are made of the same proprietary Collamer material as the Visian.

If STAAR hits a home run with the Visian, the company becomes a cash-generator with funds available to more easily support other growth initiatives.

An Improved Design

Early versions of the Visian, then called simply the ICL, did not perform well in clinical trials because they were associated with cataract formation. However, the improved design of the Version 4 ICL drew praise in the pivotal trial that led to FDA approval.

John A. Vukich, M.D., medical director of the Davis, Duehr, Dean Center for Refractive Surgery in Madison, Wis., who served as medical monitor for the North American clinical trials for the ICL, says STAAR's Version 4 ICL showed a far lower incidence of opacities in clinical trials than previous versions of the ICL.

"The vault was lengthened in the new design, and it made an enormous difference," says Dr. Vukich.

The 3-year pivotal trial that led to the approval of the Visian included 526 eyes of 294 subjects. The mean refractive error was -10.1D, with a range of -3 D to -20 D. One third of the eyes had less than -8 D of myopia. The average age was 36.5. Patients had to have an anterior chamber depth of at least 2.8 mm to qualify for the study.

At 3 years postop, 81% of the eyes were 20/40 or better and 41% were 20/20 or better uncorrected. These data are complicated by the fact that a significant number (69%) of these highly myopic patients did not have 20/20 BSCVA preop and/or were not targeted for emmetropia. The total cohort also included eyes with up to -2.5 D of astigmatism.

Among those with preop BSCVA of 20/20 and who were targeted for emmetropia, 95% were 20/40 and 59% were 20/20 or better uncorrected. Approximately 60% of the eyes had postop UCVA as good as or better than their preop BSCVA.

Patient satisfaction rates were high, with 92% very or extremely satisfied. Almost all (97%) said they would have the procedure again.

About half of the patients gained one or more lines of BSCVA compared with only 8% who lost one or more lines of acuity."

The incidence of cataract was similar for the Verisyse and the Visian. Each had about a 2% cataract rate. Neither the Verisyse or Visian was associated with IOP increases or glaucoma. Rates of postoperative inflammation and increase in refractive cylinder were low in the Visian trial (none and 0.5%, respectively).

Long-term endothelial cell loss has been another concern with phakic IOLs. This is an issue that will continue to be the subject of further study. Implantation of the Visian did not cause significant cell loss during the period covered by the clinical trial. Now, 2 years after the formal trial has ended, Dr. Vukich says follow-up examinations show that endothelial cell counts have stabilized and that patient satisfaction has remained high.

"We haven't seen cataracts. We haven't seen any new problems arise. We're very pleased with what we're seeing as we gather this longer-term data," he says.

Dr. Vukich does note that accurate sizing is crucial in the implantation of the Visian.

"We are continuing to refine our sizing algorithms," he says. "We had very good algorithms before but we are always striving to improve our technique."

What Surgeons Think

Gauging the size of the U.S. market for phakic IOLs is difficult.

In Europe, where phakic lenses have been available for more than a decade, these lenses tend to occupy a niche market. STAAR says that about 55,000 of its phakic lenses have been implanted worldwide thus far, with Korea the largest international market and China holding potential for approval in the near future. The Verisyse, known as the Artisan in international markets, has been implanted in about 160,000 persons worldwide.

Though STAAR's numbers indicate that many surgeons are now showing an interest in implanting the Visian ICL, two highly regarded and credible surveys of surgeons taken regularly in the United States point to the fact that interest in implanting phakic IOls may have peaked in the 2003-2004 period, when about 80% of surgeons reported an interest in performing the procedure. At that time, phakic IOls were being hailed as an appealing opportunity for cataract surgeons to enter the refractive marketplace. However, a 2005 survey taken by MarketScope indicated that only about 30% of the surgeons surveyed planned to implant phakic IOLs.

The ebb and flow of interest in phakic IOLs may be partially explained by recent improvements in LASIK, with the advent of wavefront-guided procedures and the IntraLase FS laser (IntraLase, Irvine, Calif.) that provides bladeless flap cutting. But with the recent approval of the Visian and the attention it has gained, the 2005 survey numbers may not be the last word on surgeon interest in phakic IOLs.

"Actually, I'm surprised at the high level of interest in the Visian that we've seen from surgeons," says Dr. Vukich. "I expected interest, but not this much. I think that during the past 2 years, surgeons have gotten comfortable with the idea of the lens-based refractive procedure. They've accepted multifocals, accommodative lenses and refractive lens exchange into their practices.

"The Visian represents the modern technology of the foldable lens that can be implanted in a sutureless, small-incision procedure using a patient-friendly topical anesthetic rather than a peri-ocular injection. I know a number of surgeons who are going to be implanting the Visian as their first phakic IOL."

Given the disparity of opinions as to whether the Visian will be a niche product or take its place in the refractive mainstream, it is too early to make a judgment on the future of the Visian, or the entire phakic lens category. But like any poker player who pushes his chips into the pot, STAAR believes it holds a winning hand.