Medical Device Daily Contributing Writer

LAS VEGAS — The annual meeting of the American Academy of Ophthalmology (San Francisco), the largest gathering of eye physicians in the world, took place over this past weekend at the Sands Expo Convention Center.

As is common at medical trade shows, public and private company managements used the convention as an opportunity to meet with Wall Street analysts and money managers.

IntraLase (Irvine, California) is the developer of an ultra-fast laser-based technology that is used to create a corneal flap prior to laser refractive surgery. Over the past several years, excellent clinical results and aggressive marketing have enabled the company to wrest significant market share from conventional microkeratomes and enjoy rapid revenue growth.

The company is now heavily promoting a new corneal procedure, dubbed IntraLase-Enabled Keratoplasty (IEK). Initially launched in September 2006 at the annual meeting of the European Society of Cataract and Refractive Surgeons (Dublin, Ireland), IEK is the first blade-free laser approach used to incise corneal tissue.

The acknowledged accuracy of IEK enables the surgeon to create precisely shaped incisions that join the cornea and the transplanted tissue together like puzzle pieces. The laser’s precision should improve the transplant experience — by requiring fewer sutures, providing a more stable graft, and enabling faster healing time and better visual recovery.

Although relatively few procedures have been performed to date, the early evidence is quite promising. CEO Bob Palmisano told analysts that “clinical results will drive market adoption and we now have some evidence that our approach will produce superior results.”

Palmisano reported that in a study of 33 corneal transplant patients, nearly half the patients achieved distance vision of 20/40, which would enable them to drive — a huge improvement over their pre-operative distance vision.

He further noted that the annual global market for corneal transplants approximates 100,000, roughly one-third in the U.S. The company has begun an upgrade program for its installed base of about 500 lasers, at about $50,000 per upgrade. In addition, it will offer new laser shipments that include the IEK hardware and software at a $425,000, or a $50,000 premium to lasers without IEK.

Roger Steinert, MD, a highly-regarded and experienced ophthalmologist from The Eye Institute, University of California-Irvine (UCI) and one of the first IEK users, spoke enthusiastically about IEK.

“This technology was a dream a mere three years ago and is now the buzz of every corneal meeting,” he said.

He said that he has performed 16 IEK procedures to date at UCI with up to nine months of follow-up. He reported that his IEK results were considerably better than with conventional corneal transplant technology, with patients achieving faster recovery and better overall vision.

Steinert concluded his remarks by saying that “IEK is the first major advance in corneal transplantation since 1970, and I believe that the IntraLase laser will rapidly become the gold standard for quality corneal transplant surgery.”

Strong technology leadership was also the theme at another analyst meeting, this one hosted by Advanced Medical Optics (AMO: Santa Ana, California).

CEO Jim Mazzo said, “we want to make a defined difference with our technology. Our charter is to create a paradigm shift, not fight for market share in existing markets.” AMO presented the analysts with four different eye physicians, each presenting on a different aspect of AMO’s diverse ophthalmic surgical technologies.

The first speaker was Steven Schallhorn, MD, a former Navy “Top Gun” pilot who heads the Navy’s refractive surgery research at theNaval Medical Center (San Diego), Schallhorn spoke on the topic of “The Importance of Spherical Aberration Correction,” emphasizing the value of AMO’s wavefront-guided laser vision correction (LVC) technology.

This technology has dramatically improved the outcomes of LVC by eliminating laser-induced spherical aberrations in the patient’s vision. Although the majority of patients are achieving 20/20 or even better vision with LVC correction, their quality of vision, as measured by contrast sensitivity, may not be nearly as good as the raw data suggest.

Schallhorn noted that the reduction or elimination of corneal spherical aberrations, which is available from AMO’s VISX division, “clearly improves the quality of vision.” As a result of extensive research into spherical aberrations, the U.S. Navy now requires all LVC procedures to include wavefront guidance.

In a similar vein of improved visual outcomes, Ralph Chu, MD of the Chu Vision Institute (Edina, Minnesota), voiced his strong support for the use of another AMO product, the Tecnis intraocular lens (IOL).

Chu said that the Tecnis lens was specifically designed to counterbalance the spherical aberrations of the cornea which increases as we age. A study of Tecnis showed an impressive 43% increase in contrast sensitivity, a critical measure of the quality of a patient’s vision.

Indeed, the Tecnis IOL is the only IOL approved by the FDA that is indicated to improve functional vision, thus providing a meaningful safety benefit for older drivers who are the usual recipients of an IOL.

Additionally, this lens has been granted a designation of “New Technology IOL,” which provides for an additional $50 per lens reimbursement from Medicare.

Chu closed his remarks by saying that Tecnis is “my monofocal lens of choice for nearly all of my patients.”

Strong endorsement for two other AMO products was provided by Dave Hardten, MD, of Minnesota Eye Consultants (Minneapolis, Minnesota) and Louis Probst, MD, medical director for the TLC Laser Vision Center (Chicago).

Hardten addressed the controversial issue of “Success with Multi-focal Intraocular Lenses,” a topic stirring widespread debate because of the intense marketing battle raging between AMO, Alcon (Fort Worth, Texas) and privately-owned Eyeonics (Aliso Viejo, California).

Hardten’s contended that today’s ophthalmic surgeon needs to be aware that patients are more demanding and knowledgeable than ever, and the physician must carefully consider their unique vision needs.

He described these lenses as “anti-aging technology for sophisticated patients” and said that his preferred IOL was the AMO’s ReZoom lens.

Probst’s talk discussed AMO’s iris registration technology, describing it as a “state of the art and a superior way to perform custom laser vision correction surgery.”

Iris registration is effective because it facilitates lining up the laser more precisely prior to the ablation of corneal tissue, thus giving greater accuracy and a “better visual outcome for patients, especially though with complex astigmatism.”

Probst, a relatively young physician, is clearly an aggressive adopter of new technology, doing virtually every procedure with the Intralase laser and AMO’s wavefront-guided software package.