Presenters tout big advances with lasers in cataract surgery

By Larry Haimovitch

Medical Device Daily Contributing Writer

March 29, 2011

SAN DIEGO — The annual symposium of the American Society of Cataract and Refractive Surgery (ASCRS; Fairfax, Virginia), has been taking place here the past few days and, similar to last year's meeting, femtosecond laser-assisted cataract surgery (FLACS), has been the overwhelmingly dominant topic.

As ASCRS got underway, Bausch + Lomb (B+L; Rochester, New York) and Technolas Perfect Vision (TPV; Munich, Germany) reported that they have agreed in principle to a deal whereby B+L will globally distribute the TPV femtosecond laser which is "capable of performing both cataract and refractive procedures on one platform." This distinguishes TPV from the other FLACS players, whose devices are dedicated solely to cataract surgery.

TPV, a leading ophthalmic laser company, was established in April 2009 through a joint venture between B+L and 20/10 Perfect Vision (Munich) to develop advanced refractive and cataract technologies. Financial terms were not disclosed. Medical Device Daily's industry sources believe that B+L currently owns about 55% of TPV.

Under the arrangement, TPV will develop and manufacture its innovative femtosecond cataract and refractive laser system from its state-of-the-art facilities in Munich and service the product through its current worldwide service organization. Bausch + Lomb Surgical will leverage its cataract expertise and commercial capabilities to globally distribute TPV's femtosecond laser.

"Femtosecond laser technology for cataract procedures promises to be one of the most significant clinical advances in cataract surgery in 40 years," said Robert Grant, chief executive officer and president of Bausch + Lomb Surgical.

"The TPV femtosecond laser platform, which uniquely supports refractive and cataract procedures, is a natural complement to our portfolio of cataract products."

"Our strength and proven experience in laser technology, manufacturing and service are a perfect complement to Bausch + Lomb Surgical's global partnership with the ophthalmic community, cataract expertise and marketing and sales abilities," said Dr. Kristian Hohla, chief executive officer of TPV.

Commercialization is expected to begin in the second half of 2011. TPV is not currently FDA approved and has previously announced that they have filed for various 510(k) clearances.

The first domestic FLACS procedure was performed about 13 months ago by Stephen Slade, MD, Slade & Baker Vision (Houston), who utilzed the LenSx (Aliso Viejo, California) laser. Venture capital-backed LenSx was acquired in mid-2010 by industry juggernaut Alcon (Fort Worth, Texas) for $367 million upfront, which could approximately double if all milestones are achieved.

FLACS technology was featured prominently in many sessions here. The barrage of superlatives to describe FLACS has been overwhelming, with terms like "game changing," "paradigm shifting," "new era," "tremendous, landscape-changing technology," and "changing the face of cataract surgery," gushing from the many speaker presenters.

The key reason for this ebullience is that FLACS technology promises to automate what is essentially a manual procedure. While the most talented cataract surgeons generally have achieved excellent results, the "average" surgeon or resident often achieves a sub-optimal result. This could be reflected in a host of safety issues (e.g., vitreous loss, anterior capsule tears, serious eye infections) or a poor visual outcome (i.e., not within 0.50 diopters of plano or 20/20 vision).

In discussing this technology and its impact on surgeons, a veteran IOL industry pundit recently told MDD that "this technology will make a mediocre surgeon very good and make a very good surgeon really outstanding."

The tone of this FLACS "love-fest" was set on Thursday night, when a packed room attended a symposium titled "The Future of Laser-Assisted Cataract Surgery." Supported by an educational grant from Alcon, it featured the most prominent cataract/refractive surgeons in the world, a veritable "who's who" in ophthalmic surgery, who addressed diverse topics relevant to this fledgling but rapidly emerging new technology.

Slade, who has performed virtually all of the several hundred domestic procedures to date, noted that the biggest benefits are a 54% reduction in phaco-emulsification (lens breakup) ultrasonic power requirements and a 60% decrease in endothelial cell loss.

Harvey Uly, MD, from the Asian Eye Institute (Manila, Philippines) and an investigator for LensAR (Winter Park, Florida), has performed about 500 surgeries. He cited several reasons to adopt this technology, including the surgeon's desire to perform better, a competitive advantage compared to others and the patient's willingness to pay a premium for a safer and more effective outcome.

Another prominent surgeon from outside the U.S., Kasu Prasad Reddy, MD, Maxivision Eye Hospital (Hyderabad, India), who has used the TPV system, noted that ". . . the biggest benefit is easy and perfect capsulotomy extraction."

Importantly, Reddy indicated that he has seen no complications to date stating that this technology " . . . allows the surgeon to reduce the impact of as many variables as possible . . . the less surgeon dependent, the more predictable the outcomes . . ."

Another symposium, sponsored by OptiMedica (Santa Clara, California) and titled "Developments in Femtosecond Laser Cataract Surgery with the Catalys Precision Laser System," showcased the advantages and benefits of this system as presented by some members of the company's medical advisory board.

John Vukich, MD, from the Davis Duehr Dean Center for Refractive Surgery (Madison, Wisconsin) cited two key features of the Catalys system, its liquid optics interface and integral guidance. The former gently docks the patient to the system and is designed to provide a clear optical path for real-time video, OCT imaging, and laser treatment. The docking mechanism minimizes a rise in intraocular pressure, which is particularly important for older cataract patients and scleral contact of the interface reduces the redness of the eye after surgery.

With integral guidance, the ocular surfaces are visualized by a proprietary, integrated optical coherence tomography (OCT) system, which is enhanced by sophisticated algorithms designed to ensure that the femtosecond laser pulses are delivered precisely to the intended location.

The enthusiasm for FLACS was clearly seen on the floor of the exhibit hall, where the booths of all these companies were buzzing with activity. It appears that Alcon will be the first to the market, having attained the required FDA 510(k) approvals. Modest commercial shipments may begin in the second quarter, with a stronger ramp in 2H-2011. Meanwhile, OptiMedica, LensAR and Technolas are likely to begin commercial activities in the second half of 2011, though their initial manufacturing capacity is likely to limit a significant number of shipments.

While the fervor for this technology is phenomenal, pegging the market potential and size is a huge challenge. How will surgeons cope with the enormous $400-500K capital cost and the sizable "per click" fee that each manufacturer is likely to impose? Informal surveying of industry sources by MDD at the conference revealed estimated penetration rates of U.S. cataract procedures in 2016 that varied widely from a low of about 15% to a high of 50%.

A crucial uncertainty concerns how these procedures will be paid for. Today, Medicare and private carriers will not cover this extra expense above conventional cataract surgery but in the future could conceivably allow the patient to pay for the extra expense out of pocket. This would be similar to a ruling that was established several years ago to allow out of pocket payment by Medicare patients for premium IOLs such as multi-focals and accomodating varieties.

These premium IOLs account for less than 10% of the domestic IOL market and slumped significantly in the past two years as the economy declined. So, how will patients react to another significant "upcharge" to gain the benefit of a laser cataract procedure, particularly in uncertain economic times?

Another key issue is that while FLACS may reduce the actual surgical time, it may boost the total time of the procedure because of logistic issues in the ambulatory surgical center. In addition, Doug Koch, MD, professor of ophthalmology at Baylor College of Medicine (Houston), noted that a FLACS laser "will impact everything from space to surgical workflow to staffing."

Perhaps the key takeaway from this meeting is: "fantastic technology, but how it be paid for?"

ASCRS Symposium

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