BBI Contributing Editor
After more than 10 years of regulatory stifling, refractive surgeons can now choose from among six different laser systems, with several others on the horizon. Although excimer lasers manufactured by Visx (Santa Clara, California) and to a lesser degree by Summit Technology (Waltham, Massachusetts) have dominated the U.S. refractive market until lately, the tides are definitely shifting. In addition to last December's ruling by the International Trade Commission that Nidek's EC-5000 excimer laser does not infringe Visx patents, Bausch & Lomb Surgical (Claremont, California) received FDA approval in March to market its Technolas 217 excimer laser in the United States. In addition, LaserSight (Winter Park, Florida) recently received FDA approval for the LaserScan LSX scanning spot system, and has started shipping to domestic customers. These recent developments have given refractive surgeons and corporate laser centers an array of options regarding acquiring excimer lasers.
"It's not clear that the recently approved excimer lasers offer clinical advantages, but I'm definitely intrigued by them," said Robert Maloney, MD, a refractive surgeon in private solo practice in Los Angeles. "I think the most interesting excimer laser from an economic point of view is the Nidek, because I'm a high-volume surgeon," said Maloney, who currently uses only the Visx laser. On the other hand, the Technolas 217 "isn't particularly interesting, because it has limited approvals and has the same royalty fees as the Visx." Likewise, Maloney discounts Summit's Autonomous LADARVision "because it is very physician-unfriendly. It is very hard for doctors to use and it is very hard for patients to fixate. The purported advantage of this laser is better centration. However, we're getting reports of increasing numbers of decentrations." Maloney said he believes that Visx "will see real erosion of market share" over the next few years, but by lowering its per-procedure fee from $250 to $100 (plus a $10 charge for each key card ordered), "this may stem the hemorrhaging of its market share." In essence, "now that the royalties are competitive, I think the only changes we will see in preference is from Visx to Nidek."
Bennett Chotiner, MD, is in private group practice in Harrisburg, Pennsylvania. "We're certainly looking at whatever new technology comes along," said Chotiner, who uses the Summit Apex Plus/ Infinity system. "But we're achieving great results with the Summit." However, Chotiner conceded that "a small-spot laser offers distinct advantages for a customized ablation." Unlike some of his peers, Chotiner has never objected to paying higher royalty fees. "This allows the laser companies to upgrade their equipment and provide service," he said. Still, Visx's erosion in the market "is already beginning to occur. I think there is going to be more competition overall." Specifically, "I think we'll be moving over to flying-spot lasers with eye trackers. Customized ablations or wavefront technology is going to be the technology of the future. We'll be able to measure not only the refraction of the patient but actually the dynamics of how light rays enter and exit the eye, as well as creating corneas that may improve vision even over a patient's previous best-corrected vision."
Jonathan Christenbury, MD, who is in group private practice in Charlotte, North Carolina, uses both the Nidek EC-5000 and the Technolas 217. He would be hard-pressed to change lasers. The Nidek "offers very fast ablation and treatment. It is also very good at correcting astigmatism," Christenbury said. "Nothing ever goes wrong with the laser. The maintenance is so simple." Likewise, the Technolas, which also is a scanning laser, "is very good at correcting astigmatism, especially when there is more astigmatism than myopia. One-day vision is excellent with the laser." In addition, "you can vary the minimum optical zone diameter."
Al Kildani, a research analyst at Pacific Growth Equities (San Francisco, California), said he believes new-generation excimer lasers are particularly enticing to new surgeons as well as startup and expanding laser centers." You can purchase the technology that has been basically unchanged since the mid-1990s, or you can buy a laser that really doesn't cost you that much more but positions you to improve outcomes for the future with add-on features like customized ablations," Kildani said. "I believe in the long term we will see better clinical outcomes from the small-spot, scanning beam lasers."
Kildani identified three excimer lasers that fall into this category: Summit's Autonomous LADARVision, LaserSight's LaserScan LSX, and Bausch & Lomb's Technolas 217. "I feel these are the three best lasers available in the U.S. market right now," he said.
Kildani also predicted that Nidek will become less of a factor in the marketplace because the company is still dependent on old broad-beam technology and that other manufacturers have significantly scaled back their pricing. Similarly, "unless Visx introduces a new laser technology platform – either through acquisition or internal development – I would expect them to plummet to about 25% of the market in three years." However, he added, "we know Visx has spent a lot of money on R&D, so it may be developing a new laser that could effectively compete with these new-generation lasers. An acquisition is also possible that would catapult the company into the lead market position again."
The Visx and the Autonomous LADARVision are the two excimer lasers currently used by Joseph Dello Russo, MD, who is in private group practice in Bergenfield, New Jersey. "Although the LADARVision is not as user-friendly as the Visx or Summit Apex Plus/Infinity, the company is upgrading rather quickly. I believe that LADARVision will become very convenient in a short period of time," Dello Russo said. "I particularly look forward to XYZ focusing." In any event, "the future of laser vision correction is going to be dependent on a tracking and scanning laser," Dello Russo said. "You have all-scanning lasers now – Nidek, LaserSight's LaserScan and the Technolas – but there is only one laser that has a tracker: Autonomous LADARVision. A tracker is most amenable to what we're all looking forward to, which is developing the technology for a customized cornea." In contrast, "scanning alone doesn't mean anything." Dello Russo also likes the fact that the LADARVision has the smallest flying spot at 0.9 mm.
Daniel Durrie, MD, a refractive surgeon at Hunkeler Eye Centers in the Kansas City, Missouri, area, actively uses four excimer lasers: Summit Apex Plus/Infinity, Nidek EC-5000, Technolas 217 and the LADARVision. "I don't have a Visx because it is the same technology as my Summit. These are both first-generation, broad-beam lasers," Durrie said. "The flying spot lasers and the flying slit laser from Nidek will have the potential to do some of the more advanced things that we desire in lasers."
Still, Durrie is not about to dismiss Visx for the long term. "Visx is a very good company that has done a very good job of providing lasers to its customers," Durrie said. "But many customers now feel that they want to move to the next level of technology. Just like Summit acquired Autonomous to provide customers with cutting-edge technology, Visx is also considering what it will do for its next-generation platform. I'm sure Visx is not going to sit around and allow its market share to fall to 20% when it is the dominant player in the market."
Although many pundits feel refractive surgeons will rush out to purchase one of the new lasers, "there are a lot of people who already have a significant investment and a solid relationship with Visx," Durrie said. "Visx has purchased a wavefront device, so we know the company is thinking about customizing the procedure as well." Moreover, despite the enthusiasm over these new lasers, "we need to let the clinical data in well-controlled studies lead our decisions. We shouldn't let marketing hype from the manufacturers be our deciding factor." He noted that the Technolas 217 has set a new standard in clinical outcomes with its recent FDA approval.