A walk around the AAO exhibit hall revealed new laser technologies

In addition to the excimer laser manufacturers there were several non-excimer refractive laser and other refractive approaches.

DALLAS — After attending the refractive surgery subspecialty meetings before the American Academy of Ophthalmology (AAO) meeting here, I spent the next three days walking around the AAO exhibit halls, meeting with company representatives and looking at some of the new lasers and devices on display. Here are some of my observations, backed up by comments based on discussions with company officials and from press releases issued by some of the companies during the meeting.

All of the companies that have lasers approved by the Food and Drug Administration (FDA) — Bausch & Lomb, Visx, Alcon Summit Autonomous, Nidek, LaserSight and the German companies Schwind, Asclepion-Meditec and WaveLight — had their excimer lasers on display, along with the diagnostics they intend to use for performing customized ablations.

In addition to the excimer companies, there were the several non-excimer refractive lasers, as well as other refractive approaches. There were also laser manufacturers with products in the glaucoma and cataract areas. Let’s start our walk with the excimer manufacturers.

Asclepion-Meditec and Visx

Asclepion announced an exclusive cooperation in integrating WaveFront Sciences’ wavefront technology, called the Complete Ophthalmic Analysis System (COAS), into the new Asclepion Wavefront Aberration Supported Corneal Ablation (WASCA) system. They say integration of this new diagnostic with the Asclepion MEL 70 G-Scan excimer laser will enable improved visual acuity in persons with vision defects.

Both Visx and Asclepion had their preview lens systems in operation. Visx’s PreVue lens is ablated following analysis by its WaveScan wavefront device, and can be used in a phoropter to determine if the patient would be satisfied with his or her wavefront-guided ablation. Asclepion, which was the first to develop this method, uses an optical plastic slide that is ablated following analysis with its WASCA aberrometer device. It works similarly to the Visx PreVue lens. I had my eyes AWACSed (Asclepion Wavefront Aberration Correction Simulator), and even over my contact lenses I could see an improvement when looking through the simulation of correction of my higher order aberrations.

Bausch & Lomb

During the AAO meeting, Bausch & Lomb announced acquisition of the exclusive development and marketing rights for a patented novel technology called a photoablative inlay (PAI), from its inventor, Gholam Peyman, MD. The company also announced its collaboration with Stromax Technologies LLC, a privately held company based in Pittsboro, N.C., to develop this corneal inlay technology that is designed to shape the human cornea during laser vision correction surgery. The PAI-LASIK surgical procedure uses the corneal inlay in conjunction with LASIK. In the procedure, a surgeon would make a corneal flap with a microkeratome and then place the inlay onto the corneal bed. The Technolas 217 excimer laser would be used to ablate and reshape the inlay, rather than the patient’s corneal tissue as is done with standard LASIK, to create the intended correction.

The ablation would be based on information from Bausch & Lomb’s integrated diagnostic system, which identifies abnormalities throughout the patient’s eye and creates a personalized laser treatment. The new PAI-LASIK procedure has the potential to extend the range of myopia correctable by LASIK and can for the first time make the LASIK procedure reversible if necessary, or could be used to make adjustments in a patient’s correction over time.

Bausch & Lomb will work with Peyman and Stromax throughout the product development process. The development team’s first task is to identify the corneal inlay material that will produce the best results. Once a material is selected, clinical studies will begin in the United States and abroad.

Finding the right material is not an easy task. In the past, a number of hydrogels and other synthetic materials have been tried as stromal implants, but to date the only one that appears successful in keeping the stromal tissue viable is the PermaVision hydrogel called Nutrapore from Anamed. We wish Bausch & Lomb well in this endeavor.

Q-Vis

One of the new companies I looked in on was Q-Vis (formerly known as Telco), which introduced its new Eye:Q2 solid-state (no gases) refractive laser system, operating at 213 nm in the ultraviolet. The laser is based on a quintupled, Q-switched Nd:YAG that uses a series of doubling and mixing crystals to bring the 1064 nm of the YAG down to the operating wavelength of 213 nm. The laser has a variable-size scanned beam, operating at 20 Hz, which starts at 0.5 mm and increases in size to 4 mm for producing up to a 10-mm treatment zone. Some of the features incorporated into the new laser include a three-axis movement bed layout, miniaturized ergonomic design (nearly everything, including the laser head, is incorporated into the bed) and network-linked touch screen user interface. The laser incorporates a 200 Hz video eye tracking system with 200 Hz feedback.

According to company officials, the first two of at least four systems have been placed in the United States for beginning FDA human clinical trials, with the first cohort of 50 eyes completed in September under an investigational device exemption. The testing was accomplished by David Dulaney, MD, of Phoenix, and Alexander Hatsis of Long Island. Clinical data will be reviewed over the next few months as Q-Vis seeks regulatory approval here and in major markets of Europe. The laser is approved for sale in Australia and is in operation at the Lions Eye Institute of Western Australia.

SurgiLight

SurgiLight made news just before the AAO by announcing it had completed its acquisition of the ophthalmic laser division of Premier Laser Systems in an all-cash deal valued at $3.72 million. At the meeting, the company displayed its IR-3000 fiber-coupled erbium:YAG laser, operating at 3 µm, reportedly the world’s first laser system designed for presbyopia reversal.

During the two refractive meetings before the AAO, SurgiLight investigators presented information on 97 cases of laser presbyopia reversal (LPR) performed by two groups of physicians in Venezuela and Argentina. The clinical results indicated that LPR is safe and effective and may offer advantages over other non-laser methods including simpler, faster operation with minimal regression. The company has not yet received FDA clearance to perform presbyopia reversal in the U.S. but expects to begin clinical studies soon. The company said it also intends to continue the ongoing clinical trials in cataract treatment and other ophthalmic applications using the Premier erbium laser.

WaveLight

After hearing rumors that there may have been problems with this company’s U.S. FDA clinical trials, I met with the CEO and learned that there had been some problems with the early results in the first 250 eyes studied. This caused WaveLight to make modifications in its laser, including increasing the fluence, adding a plume evacuator and making modifications to allow the system to be used in future trials with its wavefront sensor. The company’s trials are now back on track and expected to be expanded, to increase the number of sites and include an additional 1,000 to 1,300 eyes, as soon as they are given the go-ahead by the FDA, probably early this year. The company also plans to begin FDA trials with its WaveFront Analyzer early this year. WaveLight expects to file for myopia approval by the end of 2001.

ProLaser

Another German company that caught my eye was ProLaser, with both the Rodenstock DTK diode laser for laser thermal keratoplasty and a new hand-held retinal imaging system, the Rodenstock Scanoscope. ProLaser also made news with its proposed purchase of Premier Laser System’s EyeSys Corneal Topography division. ProLaser, based in Dusseldorf, Germany, will acquire the intellectual property, customer base and inventory of this division. Further, Premier and ProLaser have executed an additional letter of intent to proceed toward a merger of Premier into ProLaser at the conclusion of Premier’s Chapter 11 case. The closing of both transactions is subject to completion of due-diligence review, Premier and ProLaser board approvals, bankruptcy court approval and the completion of definitive agreements.

The DTK laser is a continuous wave diode operating at 1.9 µm. The company claims it delivers more precise thermal energy to the corneal collagen, and thus incurs less regression of effect than the Sunrise holmium laser. The laser is being used to treat hyperopia, presbyopia and astigmatism in Europe. U.S. clinical trials are expected to begin this year.

The Scanoscope provides real-time video retinal images in color or black and white (for fluorescein angiography) in a small, simple-to-use hand-held or slit lamp-mounted device, expected to sell for about $15,000. (Rodenstock also manufactures and sells a scanning laser ophthalmoscope for real-time retinal imaging.)

Sunrise Technologies

This was the breakout introduction for Sunrise, following its FDA marketing clearance of its laser thermal keratoplasty (LTK) Hyperion laser at the end of June. The company had a large exhibit area with several Hyperion laser systems on display and held a training session for new users just prior to the AAO. Before the meeting, the company announced that it had sold 48 laser systems during the third quarter, for a total of over 50 in operation in the United States. In a conversation with the company’s CEO, I learned that procedure royalty income during the third quarter amounted to $1.1 million, which at an average of about $150 per procedure (the royalty, depending on volumes, ranges from $125 to $190 per procedure) amounted to more than 7,300 procedures performed during the quarter. I was also shown the company’s new advertising promotional material, which in essence explains that “after 40, poor vision can get good — give us 3 seconds to show you.”

IntraLase

IntraLase has an interesting background. Founded in 1997, it grew out of the femtosecond ultrafast laser program at the University of Michigan and picosecond laser technology acquired from Escalon Ophthalmics, which in turn had acquired the assets of Intelligent Surgical Lasers, which was founded by Joseph Bille, originally of Heidelberg Instruments and Heidelberg University and now of 20/10 Perfect Vision. The company has introduced its Pulsion FS femtosecond laser, with its first FDA-approved application IntraLASIK for producing precise, smooth LASIK flaps without the need for a microkeratome. The Pulsion is also used outside of the United States for making the channels for inserting KeraVision’s Intacs, and eventually will be used to produce removable lenticles for refractive corrections.

As demonstrated in a video at the company’s booth, in IntraLASIK, a 3-µm, femtosecond-pulsed (10,000 Hz) scanned spot is focused on the substromal tissue through a disposable applanation lens while the eye is fixated under very low vacuum. A precise layer of tissue is dissected at the focal point of the laser beam, forming a layer of microscopic cavitation bubbles in a tightly wound spiral that creates a dissection plane with more precision and accuracy than is possible with a microkeratome blade. Because the femtosecond pulses are low-energy there is no heat damage to surrounding tissue or shock waves transmitted to the back of the eye. As a result, the flaps are accurate and highly consistent in both thickness and diameter, with a precisely positioned hinge. If the procedure needs to be aborted for any reason, it can be resumed in an hour with no adverse effects. The procedure takes about 30 to 60 seconds, and adds about 2 to 4 minutes to a LASIK procedure. Clinical trials were conducted at two U.S. sites on more than 220 eyes without problems, except for a few suction breaks. In those cases, the laser was halted and restarted within 45 seconds at the same plane in the stroma, without additional problems. The device currently can produce 8-mm flaps.

The laser is also being evaluated for therapeutic applications such as lamellar keratoplasties, anterior corneal transplants and, as noted above, creating tunnels for implantation of Intacs. The company is exploring creation of refractive lenticles by making two spaced passes within the stroma and then creating an opening to one side of the cornea for removal of the shaped lenticle. With this approach, IntraLASIK might be adaptable for treating myopia, hyperopia and astigmatism.

MedRx

This company, which I first came across at the last American Society of Cataract and Refractive Surgeons meeting in Boston, demonstrated its Refrax corneal shaping technology. A liquid polymer bio-adhesive is placed on the cornea within a tiny mold and hardens in seconds, taking the shape of the mold. Once the mold is removed, the new surface can be ablated, removing both the gel and some tissue, forming a new refractive shape. It forms a smooth anterior surface for the cornea to give precise ablations, regardless of corneal irregularities that may have existed before its use. The company expects to introduce the product at the 2001 ASCRS meeting, along with its new LazeX G Force gaussian beam laser. This low-priced excimer laser, the former Inpro laser produced in Germany, is expected to be introduced early next year.

Anamed

Anamed told me that it expects to submit documentation to the FDA early next year for treating hyperopia with their PermaVision Intracorneal Lens inlay. The lens is made from a cornea-compatible 78% water hydrogel called Nutrapore. At least 23 eyes have been implanted at five locations in the Middle East, Canada and Spain. The first application will be for correction of hyperopia, up to 6 D, with astigmatism correction in the future. One advantage of this implant, which is placed under a LASIK-type flap, is that hyperopes gain some near vision as well, probably from the prolate shape that is formed.

Tracey Technologies

I caught up with old friend Joe Wakil the day before he announced his blockbuster deal with TLC Laser Eye Centers. In the agreement, TLC will have exclusive worldwide rights to the codevelopment, use and marketing of the proprietary Tracey Visual Function Analyzer for wavefront-guided LASIK. The Tracey Visual Function Analyzer features unique “plug and play” capabilities and can be adapted for use with any small beam flying spot excimer laser currently available on the market once it is linked to the laser via software that has been developed by and is proprietary to TLC. TLC will thus enjoy exclusive rights to two of the three pieces of the Custom LASIK “puzzle” — the third piece being laser technology that is already available. Consistent with its commitment to allow patients to be treated on the laser that best meets their clinical needs, TLC intends to work with all laser manufacturers to bring Custom LASIK to market.

TLC plans to commercialize its Custom LASIK platform in both Canada and the United States as soon as possible. TLC also plans to cross-license its Custom LASIK platform to other laser vision correction surgeons and surgery companies in numerous countries, providing TLC with a share of the worldwide royalties generated from the technologies’ use.

The only question remaining is how TLC can get laser manufacturers to allow TLC to plug into the proprietary software in their lasers for producing customized ablations, when most companies have spent millions to develop their own proprietary systems.

LASIK pricing

Finally, I met Jack Moore, the business development manager for the Minnesota Eye Laser and Surgery Centers of Richard Lindstrom, MD. They have devised a unique way of using tiered pricing to combat the discount laser operators. Prices for laser vision correction start at $1,450 per eye for simple myopia (to –3 D) and hyperopia (to +1 D), with or without low levels of astigmatism (1 D or less), performed using either LASIK or PRK. Complex cases involving advanced levels of myopia, hyperopia or astigmatism are available at higher prices, determined by an eye exam. The higher prices range from $1,700 to $2,200 for higher myopias and hyperopias, with an additional $250 for up to 3 D of astigmatism or $500 for more than 3 D. Enhancements are at no additional charge if performed within 1 year of the original procedure, or for a $250 facility fee plus the royalty fee (if applicable) thereafter. Intacs run at $1,950 per eye and PTK is at $2,450. Hyperopia with Sunrise LTK is the same as for the excimer charges. An examination fee of $90 for established patients and $113 for new patients is in addition. Implantation of a refractive phakic IOL is at $2,500 per eye.

I believe this is the future direction for many if not all private practice practitioners, and even the higher-end corporate centers.

Glautec AG glaucoma treatment

Exhibiting at the end of someone else’s booth, Glautec AG, a newly-formed (1999) company based in Nuremburg, Germany, displayed its Aida excimer laser. The laser is used for performing ab interno excimer laser trabeculotomy (ELT), a new technique for treating open angle glaucoma. According to the company’s brochure, this procedure is applicable for patients that have already undergone other glaucoma laser therapies and for patients who have not had any glaucoma surgery. In the ELT procedure, 308-nm laser energy is directed through a 0.5-mm optical fiber across the eye to create new openings into the wall of Schlemm’s canal by gently ablating the trabecular meshwork. The first clinical results, with 12-month follow-up, indicate a statistically significant IOP reduction of up to 50%. As the surgery is minimally invasive, it can be performed on an outpatient basis.

Paradigm laser phaco

Another area of interest was the field of “laser phaco.” I spoke with a principal of Paradigm Medical Industries to learn what was holding up their FDA marketing approval. I was told that they had submitted data on 110 eyes, but that the FDA wanted information on 310 eyes. The company was in the process of collecting the additional data and expected to make its final submission during the first quarter of 2001, with approval expected within 3 months following the submission, or probably during the second quarter. The company showed its Photon Laser and Phaco Workstation at the AAO. It will incorporate ultrasonic phaco, laser phaco (when approved) and lasers for performing trabeculoplasty and iridoplasty and more, using multiple laser wavelengths on a single portable platform. Included in the laser setup are a doubled-YAG green laser and an 810-nm diode, along with the Photon YAG laser cataract removal device when available.

Laser Corporation and Asclepion-Meditec

I also dropped by the ARC exhibit at Laser Corporation. I learned that since approval, the company has sold about 15 Dodick Photolysis laser phaco systems in the United States and expected to sell at least 60 to 65 by the end of 2000, including 15 to 20 more in the States and the rest in Europe, where about 20 are currently being used.

I also inquired at the Asclepion-Meditec booth about how they were doing with their erbium:YAG PhacoLase system. I was told there were currently about 150 laser phaco systems in operation around the world, about half of them PhacoLases.

AMD — Zeiss Humphrey and Coherent

I met with the product managers for both the Zeiss Humphrey Visulas 690s and the Coherent Medical Opal to try to get a sense of how many PDT lasers were in place for activating Visudyne in the treatment of predominantly classic wet age-related macular degeneration (AMD). Both product managers seemed to be working from the same sheet; they both said that there were about 1,100 to 1,200 PDT activating lasers in place worldwide, with about 500 to 600 in the United States. The only difference is that Coherent has the majority share in the U.S. market, while Zeiss holds that position outside of the States. If you add up the two companies’ numbers, they appear to be sharing the worldwide market, with each having about 550 to 560 systems in place.

Visx

During their third quarter analyst teleconference, Visx announced that it was forming a collaboration with Stanford University to explore new avenues of treatment for AMD. The program will be headed by Mark Blumenkranz, MD, chairman of Stanford’s department of ophthalmology. Visx will sponsor work focused on the new areas of tissue engineering, cell transplantation (using autologous tissue) and electronic visual prosthesis development.

According to CEO Mark Logan, Stanford’s ability to create a centralized environment will allow multiple research teams to work together in a collaborative fashion. Dr. Blumenkranz will lead the team, which will include researchers in medicine, ophthalmology, neurobiology, computer science, electronic engineering and applied physics. Stanford has outstanding strengths in all these areas and its relationship with Visx and other Silicon Valley high tech firms facilitates the integration of ideas and technology for the purpose of developing novel treatments for previously untreatable diseases.

Mr. Logan mentioned that there was a product in the offing, but it would be some time before it would be ready for market. In response to the funding, Visx will have an exclusive worldwide right to market any products that result from the research efforts.

For Your Information:

• Irving J. Arons is managing director of Spectrum Consulting with offices at 4 Harvard St., Peabody, MA 01960; phone and fax: (978) 531-0939; e-mail: iarons@erols.com. Mr. Arons has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.