Medical Device Daily Contributing Writer

ATLANTA – The annual meeting of the American Academy of Ophthalmology (AAO; San Francisco), which is the largest annual gathering of eye physicians in the world, took place here over the past several days.

The gloomy economic environment has had a very negative impact on the ophthalmic surgery community, mostly so for domestic surgeons whose practices are heavily keyed to discretionary spending, primarily consumer-paid refractive surgery procedures such as LASIK.

Some areas of the U.S., especially the east and west coasts, have been reporting that LASIK volume is down 40% to 50% compared to last year.

In a talk at the Refractive Surgery 2008 Subspecialty Day, aptly titled "Current Trends in Refractive Surgery," Dave Harmon, president of MarketScope (St. Louis), discussed the dismal trend in LASIK procedures in 2008. He indicated that while first-quarter procedures were down 11%, they plunged 24% in 2Q08 and 35% in 3Q08. Moreover, he expects procedures to further plummet 41% in 4Q08.

Thus, for the full year Harmon predicted that total domestic LASIK procedures would decrease 26% vs. 2007.

His 2009 forecast also is bleak, with full-year LASIK procedures expected to decrease another 7% to about 965,000 vs. 1.032 million in 2008. In an interview, Harmon told Medical Device Daily that his 2009 prognostication could well prove to be optimistic, as it is predicated upon a recovery in consumer sentiment in 2H09.

Despite this clearly rugged outer environment, this year's AAO was very well-attended, with packed lecture halls and the exhibit area showing a steady flow of physicians and industry representatives.

One of the industry leaders, Bausch & Lomb (B&L; Rochester, New York) held a media event to provide an update of its activities. In late October 2007, B&L was acquired by the global private equity firm Warburg Pincus (New York) for a total purchase price of roughly $4.5 billion, including the assumption of about $830 million of debt. With the Warburg purchase, B&L transitioned from being a public company to a private one.

Jerry Ostrov, who joined B&L in January as chairman/CEO, told attendees that B&L is "focused on the long term" and while the current environment is choppy, he is entirely comfortable with the company's situation.

"Our financial position is solid and our revenue and earnings are steady or modestly increasing," he said.

An example of where B&L is performing well is in the presbyopic intraocular lens (P-IOL) space, where it is now approaching market leadership. The acquisition of privately-owned Eyeonics (Aliso Viejo, California) in January has been a pivotal strategic move for B&L, which prior to this deal did not participate in this high-growth, lucrative market segment.

In 2007, Eyeonics showed meteoric growth, with revenue of $34 million doubling the previous year. Growth has continued at a very impressive pace in 2008, with revenue once again expected to at least double the prior year, reaching at least $70 million.

The FDA's approval in June of the company's third-generation P-IOL, trade-named Crystalens HD, has been a key contributor in 2008. This lens is by far the company's best P-IOL model, providing excellent vision for most patients in the near (reading), intermediate (computer distance) and far distance fields. Its earlier models often did not provide crisp reading benefits in some patients.

According to MarketScope, Eyeonics' share has reached about 40% of the P-IOL domestic market at the end of 3Q08, up from about 26% at the close of 2007, challenging industry leader Alcon (Fort Worth, Texas). The latter's share has declined to the mid-40s in the latest quarter.

Jay Pepose, MD, director of the Pepose Vision Institute (St. Louis) told attendees that the Crystalens represents a "paradigm shift" in the treatment of presbyopia and that its ability to mimic the accommodative ability of the natural lens clearly distinguishes it from other presbyopic IOLs.

"I think that accommodating IOLs represent the wave of the future and that this is the best product in its class," Pepose said.

Earlier this year, Eyeonics began to test a direct to consumer (DTC) marketing campaign in three metropolitan areas (St. Louis, Dallas and Raleigh, North Carolina) in a bid to grow the overall P-IOL market.

According to Ostrov, this DTC program is an effort "to grow our markets, not steal market share." The DTC program most likely will be broadened across the country in 2009.

Another area where B&L management is optimistic is in conventional post-cataract IOLs, where it has an excellent new product. In mid-September, the FDA approved the Akreos AO, a high-water-content acrylic, single-piece lens. It features a unique four-haptic design and aspheric optics designed to be aberration-free. Importantly, it is capable of being implanted in a very tiny, sub-2 millimeter incision.

Robert Weinstock, MD, of the Weinstock Laser Eye Center (Largo, Florida), has been one of the first users of this lens and although he has performed relatively few cases so far, Weinstock said, "I have found this lens to be remarkable. It has a very smooth delivery, fixates within the eye very easily and has beautiful centration. I am extremely impressed."

A next-generation Akreos model, the M160, will further enhance B&L's competitive position when it receives marketing clearance in the U.S. In April, this lens received the gold award at the Medical Design Excellence Awards, a leading medical awards program for the medical technology industry.

The ability of Akreos to be implanted in a sub-2 millimeter incision is especially significant because it can be implanted after removing the cataract with B&L's Stellaris micro-incision phaco-emulsification system.

Elizabeth Davis, MD, director of the Minnesota Eye Laser and Surgery Center (Minneapolis), told attendees that this device offers her the safest, fastest and easiest method to remove a cataract. Its tiny incision reduces the likelihood of surgically-induced astigmatism and infection and facilitates the use of IOLs that can be folded and inserted in a very small opening.

She said that "Stellaris is an exceptional system for all surgeons."

Closing the meeting, Ostrov made it clear that the "new" Bausch & Lomb intends to compete vigorously and wants to be "either No. 1 or No. 2 in every market it competes in."