at press time

Slump in Laser Vision Correction
Decline Correlates with Drop in Consumer Confidence.

When Hurricane Katrina ravaged New Orleans and the Gulf Coast in September 2005, the catastrophe touched off a chain of events that resulted in sharply higher gasoline prices, a drop in consumer confidence and a nationwide decline in laser vision correction procedures.

Advanced Medical Optics (AMO), which has a large stake in laser vision correction through its VISX subsidiary, recently reported that laser vision correction procedures in the United States dropped by 3% in the 12 months ended Sept. 30. This decline was one of the primary factors cited by AMO in revising its 2006 earnings estimate downward to a range of $1.85 to $1.90 per share from an earlier estimate that had projected 2006 earnings above $2 a share. AMO also reduced its earnings guidance for 2007 to a range of $2.25 to $2.35 a share.

AMO was not alone in making downward revisions. LCA-Vision, which operates more than 50 laser vision correction centers under the LASIKPlus name, trimmed 2006 estimates in what it termed "a flat-to-down market" and IntraLase, which provides technology for laser-cut LASIK flaps, missed analysts' estimates for September quarter earnings and also reduced its estimate for full-year 2006 profitability.

Since the advent of laser vision correction surgery more than a decade ago, industry analysts have been unanimous in pointing out that peaks and declines in procedure volume have correlated closely to peaks and declines in overall consumer confidence. Analysts attribute this close correlation to the fact that laser vision correction is an elective procedure whose cost comes directly from the pocket of the patient. When consumers are faced with sharply higher gasoline prices and rising interest rates, as was the case throughout most of the 12 months from Sept. 30, 2005 to Sept. 30, 2006, they tend to postpone high-ticket discretionary expenditures.

Though consumer confidence was beginning to recover from the effects of Hurricane Katrina in early 2006, fears of Iran's nuclear ambitions touched off a second round of rapid gasoline price hikes in the late spring and early summer of 2006, causing the Conference Board's Consumer Confidence Index to plunge from a high of approximately 110 in April to a low of 100 in August.

The good news is that falling gasoline prices caused the Consumer Confidence Index to rebound strongly in early autumn, which bodes well for a resumption of growth in laser vision correction procedures. Currently, AMO is predicting an increase of 2% to 4% in 2007 U.S. laser vision correction procedures.

Keratoplasty with IntraLase
Clinical Data Shows Superiority to Trephine Technique.

IntraLase Corp. has launched its IntraLase-Enabled Keratoplasty (IEK) technology, using the company's proprietary femtosecond laser to potentially make corneal transplant surgery safer, with faster healing and better visual results, for patients suffering from severe corneal disease or damage. According to IntraLase, many of the world's leading ophthalmic institutes have begun using the upgraded IntraLase FS laser, designed for corneal transplantation, including the University of California, Irvine, Corneal Research Foundation and the Bascom Palmer Eye Institute in the United States, as well as the Munich Cornea Bank and the Cornea and Refractive Surgery Department at Universidad Nacional Autonoma de Mexico.

The intraLase is capable of creating complex, shaped incisions such as the "top hat" (top) and the "zigzag."

The first laser in the United States used to create incisions for corneal transplantation, the IntraLase FS laser allows the surgeon to create complex, shaped incisions that allow the recipient and transplant tissue to fit together much like an intricate puzzle.

Instead of the straight vertical cut performed in trephine-initiated corneal transplantation, the IntraLase FS laser is programmed by the surgeon, using IntraLase's patented computer interface, to create precisely shaped incisions in both the patient's diseased cornea and the transplant tissue. Then, the laser's infrared light beam is precisely focused to a point within the cornea where microscopic bubbles are formed to establish the incision. The laser is able to create complex incisions such as the "top hat," "zigzag" and "mushroom" that are nearly impossible for the manual, handheld trephine.

The preliminary clinical work with IEK demonstrates that by creating incision edges that fit together in an interlocking design, the graft is more stable and, therefore, may heal faster.

"With the excellent safety and visual results achieved with IEK, corneal transplantation now becomes a more accessible and successful treatment option for both surgeons and their patients," said Robert J. Palmisano, president and CEO of IntraLase. "By advancing corneal transplants in the course of treatment, our technology may increase corneal transplant procedure volume over the next few years."

Data collected from 23 initial IntraLase-Enabled Keratoplasty cases demonstrate significant improvement in vision over the traditional trephine approach:

► At 3 months postop, 45% of IEK patients report visual outcomes of 20/40 or better vision, qualifying them to drive without corrective lenses.

► In contrast, a large-scale clinical study of trephine-initiated corneal transplantations showed only 30% of more than 2,200 patients achieved similar visual outcomes.

► Ninety-one percent of IEK cases report a best-corrected visual acuity of 20/80 or better at 3 months compared to 58% of trephine-initiated cases.

"This preliminary data shows that in just 1 year since the very first cases were completed, the IEK technology is making tremendous improvements in a procedure that we have been performing and developing for more than half a century," said William Culbertson, M.D., director of the Bascom Palmer Eye Institute and professor of ophthalmology at the University of Miami. "It is impressive that our early IEK cases compare so favorably against a study of 2,200 of the best trephine-initiated cases. I believe even greater results with IEK are on the horizon as we all continue to advance our technique."

With the announcement of the first IEK corneal transplant cases in January 2006, surgeons at several leading U.S. ophthalmic centers have now used the IntraLase FS laser to make incisions in more than 100 successful corneal transplant surgeries. IntraLase received U.S. FDA clearance for the laser's use in penetrating keratoplasty procedures in September 2005.

GIVING BACK:A World View of Ophthalmic Training
Dr. Karl Golnik is Teaching the Teachers of Ophthalmology.
By Leslie Goldberg, Assistant Editor

Karl C. Golnik, M.D., has a strong desire to improve the skills of doctors in terms of their teaching abilities. "Physicians involved with residents are not really ever taught how to teach," says. Dr. Golnik. "It's just assumed that they can, which is certainly not true. Most have never had any formal instruction in teaching."

Dr. Golnik, professor of ophthalmology, neurology and neurosurgery and residency program director and vice-chair of the Department of Ophthalmology at the University of Cincinnati, received his masters degree in education shortly after recognizing this desire to educate the educators. Growing up with both of his parents being teachers, he says he has always been drawn to the profession.

To realize his goal, Dr. Golnik and Andrew Lee, M.D., professor of ophthalmology, neurology and neurosurgery at The H. Stanley Thompson Neuro-ophthalmology Clinic and director of residency curriculum at the Department of Ophthalmology at the University of Iowa Hospitals and Clinics, have developed a 2-day course called "Educating the Educators," designed to facilitate improvement of faculty teaching.

Dr. Golnik (left of board) makes a point.

Dr. Golnik emphasizes that the course is all about teaching educators how to teach. After taking the course, participants will be able to implement a step-wise approach to curriculum development, learn techniques to improve teaching effectiveness, gain knowledge and ophthalmology-specific tools to assess resident competence and understand the intricacies of program accreditation and individual certification in the United States and other countries." In all, the course is 4 half days of teaching.

Shortly after the development of the course, the International Council of Ophthalmology (ICO) heard what Drs. Golnik and Lee were doing and stated their interest in the course. The ICO wanted to offer the program to other countries to facilitate teaching effectiveness globally.

The ICO and the doctors collaborated on a project, leading to the first ICO program directors' course. The program focused on improving teaching skills. It was held in Mexico City in 2004. Dr. Golnik co-directed the program along with Enrique Graue, M.D., president of the Pan-American Association of Ophthalmology. The second international program was held in Lima, Peru, in March 2006. The third was in Cairo in June. The doctors are currently getting ready for a meeting in Lahore, Pakistan, that will include Afghans and Indians in addition to Pakastanis.

"Our ultimate goal is to improve patient care," says Dr. Golnik. "We are promoting education of teaching ophthalmologists around the world so that they can teach better. This will help their students to become better ophthalmologists."

The program has received positive feedback all along the way and the doctors are now developing a follow-up program to present at the 26th Pan-American Congress of Ophthalmology to be held in June in Cancun, Mexico. Dr. Golnik is currently organizing a symposium with the intent of getting those educational directors who were at the first two meetings to come back and give presentations on how they have implemented what they learned from the initial program.

The Educating the Educators program is intended for program directors or those responsible for training future ophthalmologists. It is designed to be interactive with small-group discussions and brainstorming sessions. One section is dedicated to the previously developed ICO Resident Specialist Curriculum, written by Dr. Lee and Mort Goldberg, M.D. It is a 90-page document available on the ICO Web site (www.icoph.org/pdf/ICOResidencyCourse.pdf).

"The document lists ophthalmology topics that residents should know," says Dr. Golnik. "The problem with the document is that it is targeted to Americans and what they should know. We are trying to convince regional educators to revise it to match their country or region's issues."

Bruce Spivey, M.D., president of the ICO and Bradley Straatsma, M.D., president of the ICO Foundation, have championed the ICO PD meetings and were instrumental in seeing that the initial vision became a course. Other speakers include Dr. Lee, Anthony Arnold, M.D., Alfredo Sadun, M.D. and Peter Quiros, M.D. All are highly involved with the program and receive no monetary reimbursement.

IN THE NEWS

■ New crystalens design. Eyeonics, the developer of the crystalens accommodative IOL, has introduced the crystalens Five-O. The new crystalens Five-O has been redesigned to include new features: the optic size has been increased from 4.5 to 5 mm; the plates are parallel rather than trapezoidal; there is 17% greater surface area for contact between the optic, plates and capsular bag, with 90% more plate arc length.

According to eyeonics, surgeons' preference for a larger optic led to the development of the redesign that will increase the ease with which surgeons can implant the lens. The parallel pockets will lead to greater plate motion by creation of a uniform width pocket in the capsular bag. The increase in surface area and arc length will further enhance predictability and capsular bag support. Crystalens Five-O is inserted with an injector through a 2.8-mm incision.

■ OSI to exit eye care. A little more than a year after acquiring Eyetech and its Macugen treatment for wet AMD, OSI Pharmaceuticals has determined that the controversial $650 million acquisition was a failure.

With Macugen sales plummeting from a rate of more than $50 million per quarter prior to the June approval of Genentech's competing drug Lucentis to approximately $9 million in the 3 months ending Sept. 30, OSI will try to recoup a fraction of its investment by either licensing, selling or partnering Macugen. The company, which made the announcement as part of its September quarter earnings release, said Macugen failed to deliver the cash flow that had been anticipated.

When the planned acquisition was first announced, Lucentis, then in late-stage clinical trials, had already demonstrated a major efficacy advantage over Macugen.

"It is evident that a key strategic goal behind our acquisition of Eyetech — generating positive cash-flow from the eye business in the 2006-2008 period — will not be realized," stated Colin Goddard, Ph.D., OSI's CEO. OM

Correction: The Web site address that should have appeared for Sonomed in the October Marketplace section is www.sonomedinc.com.