Medical Device Daily Contributing Writer

SAN DIEGO — The annual symposium of the American Society of Cataract and Refractive Surgery (ASCRS; Reston, Virginia), held here the past few days, enjoyed record attendance as the swift pace of innovation has made this meeting increasingly popular in recent years. Another driver is the convergence of an aging population with rising disposable income and new ophthalmic technologies.

This convergence, according to an article in the ASCRS newsletter, produced by Eye World, is creating a "perfect storm" for ophthalmologists. Similar sentiments were expressed at a meeting sponsored for clients of the highly-regarded consulting firm Market Scope (Manchester, Missouri).

One of the key trends is the evolution to private consumer payment of leading refractive technologies, best reflected in the current growth rate of the $1.6 billion global intraocular lens (IOL) market. Market Scope's Bill Freeman, a veteran of 30 years in ophthalmology, predicted that this market will grow at 10% or better annually in the next five years, with about two-thirds of this coming from a shift to premium-priced phakic and refractive IOLs.

Unit growth, boosted by an aging global population, was forecast at a modest 3%-4% annually. Prior to the advent of the premium-priced IOL segment, the global intraocular lens market was growing at less than 5% annually. Another major trend is the huge growth potential of Asian ophthalmic surgery markets.

For example, Market Scope principal Dave Harmon estimated 650,000 IOL implants in China in 2006, a paltry penetration rate in a country with about 1.3 billion citizens. By contrast, there were about 2.8 million IOL implants in the U.S. in 2006 with a population of 300 million. "We believe that the Chinese market will grow at a 20% annual rate for the next several years," said Harmon. One of the industry's ophthalmic surgery leaders, Advanced Medical Optics (AMO; Santa Ana, California), held a "Technology Update" to showcase its multiple technologies to members of the investment community.

Leonard Borrmann, executive VP for R&D, said that AMO's goal is "to populate the vision care life cycle with innovations that serve a lifetime of a refractive needs."

He said that AMO is well-equipped with a broad-based product portfolio, which includes contact lens solutions, phakic IOLs and laser refractive surgery technologies for the younger patients, and an array of monofocal and multi-focal IOLs and cataract surgery equipment for both middle-aged and senior patients. Borrmann said that the company's strategic objectives have three major thrusts.

• first, provide superior, differentiated technologies that serve premium markets and deliver high margins;
• second, focus R&D on innovations with market-changing potential;
• third, optimize the leverage inherent in its world-class R&D teams.

Borrmann said that AMO's global R&D spending has increased from just under $30 million in 2002 when it became an independent company to an estimated $68 million in 2007. Importantly, its R&D spending as a percentage of sales has risen from 5.6% in 2002 to an expected 6.8% for 2007.

In addition to its internal development, AMO has demonstrated a willingness to look outside its organization for technology leadership. In 2007, it has completed two key technology acquisitions: buying IntraLase (Irvine, California) for about $800 million in March (Medical Device Daily, March, 2007) and WaveFront Sciences (Albuquerque, New Mexico) in January for about $20 million (MDD, Jan. 2007). IntraLase, a well-recognized name in ophthalmic surgery, pioneered the concept of a laser microkeratome for creating the corneal "flap" that precedes a LASIK "zap."

It has rapidly garnered share in recent years from conventional microkeratomes, fueled by clinical evidence that it produces better results, plus a strong marketing effort. With the IntraLase purchase, AMO is the only company that can offer an all-laser-based LASIK procedure. Many consumers find that this enticing, as they perceive the laser to be a superior surgical tool for flap creation prior to LASIK. Dan Neal, WaveFront's chief scientist and a technical advisor, said that WaveFront "possesses a robust technology platform, which provides powerful synergies with AMO's products."

These include the potential to provide improved diagnostics for AMO's next generation of IOLs, a better capture range for its CustomVue excimer laser refractive surgery treatments, better outcomes through more accurate measurement and new technologies to accelerate improvements in product quality.

Neal noted that the marriage of WaveFront and AMO brings state-of-the-art wavefront technology in-house, connects it directly to AMO's technology and positions it to provide the key next generation refractive surgery solutions. The real world benefits of AMO's technology prowess were presented by Kerry Solomon, MD, medical director of the Magill Laser Center (Charleston, South Carolina).

"Customized excimer laser refractive surgery brings better results," Solomon said, citing and iris registration (IR) as yielding major patient benefits. And he defined iris registration simply as "the laser precisely [hitting] its intended mark." It provides the ability to compensate for two patient-related issues — pupil centroid shift and cyclotorsion. Centroid shift refers to the fact that a dilated pupil and normal pupil have a different center, which can cause the laser to ablate corneal tissue imprecisely.

Centroid shift refers to the eye's slight rotation when we lie down, also potentially affecting the accuracy of an ablation because patients are prone when the laser is active.

In a study performed at his center, Solomon treated 33 patients without iris registration and then 86 patients with it. He found that about 40% of his patients treated with iris registration enjoyed "super-vision" — that is, 20/15 or better. This compared to less than 10% in the non-IR treated patients. About 80% of the IR-treated patients had 20/20 vision, comparing favorably to the 63% at 20/20 without this advanced technology. He noted that 40% of the IR patients gained visual acuity over their previous best vision when using contact lenses or glasses.

Iris registration, he said, is fully-automated and does not require any extra chair for the clinician or any other extra cost. He concluded by saying that "these technology advances have had a huge impact on my practice and are providing spectacular visual outcomes." Richard Lindstrom, MD, founder of Minnesota Eye Consultants (Minneapolis, Minnesota), one of the world's foremost ophthalmic surgeons, cited strong financial incentives for the physician to adopt iris registration. In a supplement to an article in the January 2007 issue of Cataract & Refractive Surgery Today Lindstrom pointed out that his center's "enhancement rate" — a euphemism for the need to re-treat a poor LASIK outcome — formerly was about 10% of patients treated. With the adoption of AMO's advanced iris registration technology, the re-treatment has been halved to 5%. He noted that their analysis was that each enhancement costs his center about $750 per patient. Assuming that 1,000 patients are treated annually — not unusual for a busy refractive laser center — Lindstrom estimated the annual savings with iris registration at $37,500.