IOLs in the U.S.A.

Innovations continue to reshape the landscape of the domestic IOL market.

BY RENÉ LUTHE, SENIOR ASSOCIATE EDITOR

The aging of the Baby Boomer generation has created a metaphorical wind at the back of the cataract IOL industry in recent years, stimulating innovation and increasing profits. Since 2005, when the CMS designated three presbyopia-correcting IOLs (PC-IOLs), the crystalens (eyeonics/ Bausch & Lomb [B&L], Rochester, N.Y.), the ReZoom (Advanced Medical Optics, AMO, Santa Ana, Calif.) and the ReSTOR (Alcon, Forth Worth, Texas) for the Patient-Shared Billing program (allowing patients to pay the difference in cost between the Medicare-covered cataract extraction procedure and the lens they choose), premium IOLs have skyrocketed. This magazine's recent interviews with industry leaders confirms that the segment is both thriving and striving to offer products that improve patients' quality of life for a demographic segment that has been famously uncompromising. Below is their take on the state and direction of IOLs in the U.S. market.

Accommodating IOLs

PC-IOLs, clearly, continue to be the big story in the cataract IOL market, both multifocals and accommodating IOLs. According to MarketScope, sales of the crystalens, the only accommodating IOL approved for the U.S. market, were 40,000 units in 2007 — double its sales figures for 2006. And despite the success of the current iteration of the lens, the crystalens 5-0, B&L has a next-generation poised to enter the domestic market: the crystalens HD-100. It will be the fourth-generation of what began as eyeonics' accommodating IOL technology.

"We knew there were a couple of issues with the old crystalens 45, and that was predictability and near [vision]," explains Mike Judy, chief marketing officer for Bausch & Lomb Surgical. "We went a long way toward addressing both of those issues with the crystalens 5-0 (Figure 1). We feel like we've met and accomplished the challenge around predictability and we are always looking to provide better outcomes for both our surgeons and our patients. That's why we spent a lot of time and resources introducing the crystalens HD technology."

Figure 1. Bausch & Lomb's crystalens 5-0.

The lens is currently in an FDA multisite clinical trial. B&L anticipates launching the IOL by the end of this year.

AMO reports that it also has an accommodating IOL in the works. The company acquired the Quest accommodating IOL technology. "Our accommodating IOL's mechanism of action is confidential, but we got to kick the tires of just about everything out there, and this is the one our R&D people, our marketing people and our clinical advisors believe has the right mechanism of action to work as closely as possible to the natural crystalline lens in terms of true accommodation," says Ron Bache, global vice president of refractive IOLs at AMO.

Visiogen (Irvine, Calif.) has also entered the accommodating IOL fray, with a phase 3 FDA clinical trial for its Synchrony IOL underway. The company reports that it has completed enrollment for the dual-optic lens's trial.

Multifocal Entries

This category of PC-IOLs also has made enormous strides: According to MarketScope, approximately 5% of IOLs implanted implanted in this country in 2007 were multifocals compared with 7.2% for the first quarter of 2008.

Figure 2. Alcon's ReStor Aspheric.

Alcon's AcrySof ReSTOR Aspheric (Figure 2), launched in late 2007, is the most recently approved PC-IOL. Like the earlier AcrySof ReSTOR, the IOL features an apodized diffractive design with blue-light filtering technology. The aspheric technology the new IOL offers is not simply a carry-over from the monofocal AcrySof IQ, says Steve Speares, the company's vice president of global cataract marketing. "We did not just take that same technology and apply it to the ReSTOR Aspheric. We actually modified the asphericity component of ReSTOR to maximize the value of it in a multifocal IOL. So even the asphericity is unique on ReSTOR when compared with IQ."

A paper presented at the 2008 American Society for Cataract and Refractive Surgeons meeting by Satish Modi, M.D., examined spherical aberrations (SA) in 25 patients implanted bilaterally with the ReSTOR aspheric and compared them with patients implanted with the original ReSTOR. Aberrometry with a 5-mm pupil aperture showed SA of 0.15 with the ReSTOR group, but 0.06 with the ReSTOR Aspheric. At 1-day postop, 43% of the aspheric group saw 20/20 vs. 6% for the original ReSTOR. At 3 months, 100% of the aspheric eyes saw 20/30 or better.

AMO, meanwhile, is on the verge of releasing its third multifocal IOL, the Tecnis MF. While the company's current multifocal, the ReZoom, "provides great intermediate vision and great distance vision and is pupil-dependent, the Tecnis multifocal gives a great range of vision, but its strengths are distance and near," explains Bache. Additionally, it is pupil-independent, making it amenable to all lighting conditions, he says. AMO anticipates FDA approval for the Tecnis MF late in the fourth quarter of 2008 or early first quarter of 2009.

Careful patient profiling remains a crucial issue for success with multifocal IOLs, experts agree. "We encourage our customers to go through a disciplined process of patient selection," says Alcon's Speares. "A patient with significant astigmatism who cannot be corrected either intraoperatively or postoperatively down to 0.5 D or less is probably not the best candidate for ReSTOR Aspheric; however, that patient would be an excellent candidate for the AcrySof Toric." Other exclusionary conditions, he says, include significant dry eye disease and amblyopia.

Another factor affecting multifocal success is that these lenses require a different mindset, industry leaders agree. Judy estimates premium IOLs have only approximately a 5% penetration in the U.S. market since they became an option in 2004. Changing the mindset requires educating the entire practice staff about the lenses.

"It's not just like changing from one monofocal to another," explains Bache. "That's easy and transparent to the patient and the practice. But changing from one multifocal to another, or from a monofocal to a multifocal, there are inherent issues. You get a lot more patient feedback that you have to learn how to deal with that wasn't there when you were participating in just the normal cataract market. I think that's the bigger hurdle to the marketplace growing bigger as we go forward." He says that AMO has an outreach program to help facilitate this transition, including business development seminars on site for surgeons and their staffs.

Despite the extra effort that multifocal IOLs initially require, industry leaders believe that the market will only get better for PC-IOLs. "There's no doubt that the tide is with these PC-IOLs," says Bache. "And I don't just say that as a marketing guy. One, because they're good for the patient. As you look forward, it's clear that patients are going to evolve to the point where they are going to expect the vision PC-IOLs provide. Two, they're good business for the surgeon, with reimbursement going down, to participate in this segment of surgery. And it's good for industry to continue to bring these technologies forward. So all of the positives are aligned. It's good for the patient, it's good for the surgeon, it's good for industry. When those things line up, traditionally, those markets grow."

Monofocals Remain the Mainstay

For all the buzz about PC-IOLs in the industry, however, monofocal lenses still possess the lion's share of the market. Monofocals are still easily the biggest-selling lenses at Alcon (the AcrySof IQ), AMO (the Tecnis) and B&L (the SofPortAO).

B&L says that its SofPort IOL, an aberration-free aspheric, does "extremely well" in the United States. Further improvements are planned in the future. The company's Akreos m-160 aspheric lens is its best-selling lens in Europe, Judy reports. Addressing the trend for microincision cataract surgery, the Akreos was designed for implantation through a 1.8-mm incision. B&L hopes to bring it to the United States this year. The Akreos won a 2008 Medical Design Excellence Award.

STAAR Surgical (Monrovia, Calif.) also has been busy in the aspheric IOL segment. The company received NTIOL designation from CMS for its Affinity Collamer Aspheric IOL. "Most recently, we submitted a new NTIOL application for our STAAR Collamer Aspheric Single Piece IOL which can be injected with our new nanoPOINT delivery system through a 2.2 mm incision," says Chief Executive Officer Barry Caldwell.

Alcon's AcrySof Toric is another innovation in the monofocal group. In 2007, following the CMS' ruling that allowed patients to choose the option, MarketScope reports that 40,000 toric units were implanted — up from 12,000 units the year before. Currently, the Toric is available as a spherical lens, but Speares reports that an aspheric version is in the works. "Also, we'll be working toward increasing the range of cylinder correction," Speares says. "We're working with the FDA right now on what is required to expand the range of toricity correction in that same platform."

STAAR Surgical's Toric IOL received CMS approval in 2007.

AMO's Tecnis 1-piece, launched in April of this year, is an aspheric lens featuring three-point haptic fixation to improve stability, the company says. A 360-degree optic edge is designed to reduce posterior capsule opacification. The Tecnis 1-piece also features a frosted edge to minimize edge glare. CMS recently granted it NTIOL designation.

Coming Attractions

Industry leaders promise that more innovations are on the way to deliver today's cataract patients the quality of vision they increasingly expect. Bache believes that a combination treatment of laser vision correction over IOLs is a trend that is bound to become more prominent. "When you look at patients' expectations in terms of getting exactly the kind of vision they're looking for, I think you're going to continue to see this laser enhancement over lenses to improve both sphere and cylinder, to get patients exactly to where they want to be," he says.

Figure 3. AMO's Tecnis 1-Piece.

Microincision cataract surgery is another trend experts expect will continue to gather momentum. "The combination of a sub-2-mm incision and a sub-2-mm lens has proven to be very effective in transitioning the market in Europe and we look forward to that sometime in the future in the United States," says Judy.

Alcon is ready to support the trend with the launch of the Intrepid Micro Coaxial System. It centers around the Infinity Platform, but an important component of that, Speares reports, is the Monarch D cartridge. The cartridge "allows surgeons to truly perform small, micro-coaxial incision cataract surgery down to 2.4 mm, even 2.2 mm, without having to alter their phaco or lens insertion technique," Speares says.

Alcon is also betting on patient education, planning to launch an unbranded Web site, www.CataractSurgery.com, this summer. Company research shows that patients generally lack an understanding of their IOL options, as well as cataract surgery. "Healthcare consumers are becoming more demanding so education is probably the cornerstone for this category to continuously evolve," Speares explains.

With the current crop of innovations, chances are better than ever that cataract surgeons can deliver vision that satisfies even the most discriminating patients. OM