US Surgeons Look to Europe to
See How IOL Technologies
Compare Between Continents
BY STEPHEN G. SLADE, MD, FACS
We learn from our colleagues. In particular, US surgeons can often learn about the future of ophthalmic innovations from our colleagues in Europe. Due to the much longer regulatory approval process of the US Food and Drug Administration (FDA) compared with the Conformité Européene (CE) process in Europe, many lenses, whether developed in the United States or abroad, see their first commercial use in Europe.
So what is the current state of the IOL market in the United States compared with that in Europe? In the United States, much emphasis is placed on the premium IOL market—those cases in which doctors are allowed to charge a market- and work-based premium fee. Premium IOL technologies include three major categories: accommodating, multifocal, and toric IOLs. The first premium IOL available in the United States was the Crystalens (previously Eyeonics, Inc., Aliso Viejo, California; now Bausch & Lomb, Rochester, New York), which received FDA approval on November 13, 2003. The Centers for Medicare and Medicaid Services (CMS) ruling that followed on May 11, 2005—spearheaded by J. Andy Corley, Corporate Vice President and Global President, Surgical Products, Bausch & Lomb—authorized the current market- and work-based fee schedule. The Crystalens is the most commonly used premium lens today in the United States and, as recently as 2008, it was thought to represent more than 50% of all premium lenses used in the country (MarketScope data, 2009).
All major categories of premium IOLs are available in the United States, but with fewer choices of each compared with Europe. For example, the Crystalens is the only accommodating technology we have available; however, this lens has evolved significantly in the 8 years since its approval to the current HD model and the aspheric model. Recently, Abbott Medical Optics Inc. (Santa Ana, California) acquired Visiogen's Synchrony lens, a dual-optic accommodating IOL, but FDA approval has not been issued to date. We also have three major multifocal IOLs to choose from: Restor (Alcon Laboratories, Inc., Fort Worth, Texas), which is available in two near focal distances; ReZoom (Abbott Medical Optics Inc.); and the more recently approved Tecnis (Abbott Medical Optics Inc.). Both the Alcon and STAAR Surgical (Monrovia, California) toric IOLs are also approved.
The premium channel itself is healthy, but its penetration as a percentage of all IOLs has been small and lately stagnant at approximately 6.4% of all cases (MarketScope data, 2009). The percentage varies widely from surgeon to surgeon, with some high-volume surgeons using premium IOLs in 60% to 70% of cases and others electing not to use any premium IOLs due to the increased clinic time, reduced patient flow, and often more difficult patient expectations. In the United States, there is an assumption that few surgeons are doing most of the premium cases. Interestingly, toric IOLs have had a much higher penetration rate than presbyopia-correcting IOLs, which may be a precursor to these toric-only surgeons adopting other premium IOLs. Toric IOLs cost the surgeon less than presbyopia-correcting IOLs and are offered at a lower expense to the patient. They are thought to be more easily understood by the patient and require less chair time.
WISH LIST IN THE UNITED STATES
What should our wish list be? What do we look for across the ocean? Much of the interest in the presbyopia premium market is on accommodating IOLs, and this is largely related to their more physiologic mechanisms of action and their perceived reduction in visual disturbances relative to multifocal IOLs. We are curious how any new accommodating technology used in Europe compares with what we have available now in the states, such as the Synchrony, the 1CU (HumanOptics AG, Erlangen, Germany), and the Tetraflex (Lenstec, St. Petersburg, Florida). Surgeons using multifocals alone would be similarly interested in newer, better multifocal technologies. We would especially like to see presbyopiacorrecting IOLs—whether accommodating or multifocal—that also address astigmatism.
The percentage of US citizens over the age of 65 years will double by 2020.1 This growing market hopefully will come during a time of general economic recovery. We are richly supported by three major IOL companies based in the United States—Abbott Medical Optics Inc., in California; Alcon Laboratories, Inc., in Texas; and Bausch & Lomb, in New York—and we hope any new health care plan will preserve the economic climate for development of new technology. We also hope that any new US health care system will preserve our current flexibility for the patient to choose what is placed in his eye. Premium IOLs represent an enormous value to the patient, with high success rates, minimal risks, and maximal benefit. Consider the value of providing excellent vision to a patient that he will use every waking moment of his life after surgery. What will come next?
Stephen G. Slade, MD, FACS, is a surgeon at Slade and Baker Vision in Houston. Dr. Slade is the Chief Medical Editor of CRST Europe's sister publication, CRST. Dr. Slade states that he is a consultant to Bausch & Lomb, Abbott Medical Optics Inc., and Alcon Laboratories, Inc., and serves as the medical director for LenSx Lasers Inc. He may be reached at tel: +1 713 626 5544; e-mail: firstname.lastname@example.org.
- Civic Ventures Web site. Fact Sheet on Older Americans. Available at: http://www.civicventures.org/publications/ articles/fact_sheet_on_older_americans.cfm. Accessed December 9, 2009.
Availability of Premium IOLs
Growing Significantly in Europe
BY ERIK L. MERTENS, MD, FEBOPHTH
The US ophthalmic market is in many ways much different from the European one, with many lenses already gaining Conformité Européene (CE) approval before they can be used in the United States. For example, early experience in Europe with the Crystalens AT-45 (Bausch & Lomb, Rochester, New York) gave US surgeons the opportunity to learn from the mistakes made across the Atlantic Ocean. We learned that meticulous keratometry, precise axial length measurement, and butterfly surgery are of the utmost importance to achieve excellent results and make our patients happy. Because of these lessons, the Crystalens became the most used premium IOL in the United States. And the story continues.
In Europe, the availability of premium IOLs has grown significantly over the years. Beside the Crystalens HD and AO (Bausch & Lomb; AO not yet commercially released), we have other accommodating technologies including the Akkommodative 1CU (HumanOptics AG, Erlangen, Germany) and Synchrony (Abbott Medical Optics Inc., Santa Ana, California), which is a dual-optic accommodating IOL with a one-piece lens design that connects a high-powered anterior optic (anterior convex) and a minus-powered posterior optic (posterior concave) with a spring-like haptic design. The Tetraflex (Lenstec, St. Petersburg, Florida) received the CE Mark in 2004. (The US FDA clinical trial has been truncated, and the company anticipates approval in late 2010.) The availability of IOLs makes the choice for surgeons not always easy, with the added concern of long-term stability for new IOL designs.
Beside the three major multifocal IOLs available in the United States, European surgeons have some interesting new concepts, such as the AT.LISA and AT.LISA toric1 (previously called Acri.LISA; Carl Zeiss Meditec, Jena, Germany). The latter not only corrects distance and near vision but also addresses any possible astigmatism, which in many eyes, helps to achieve the plano target. The Mflex (Rayner Intraocular Lenses Ltd., East Sussex, Germany) has either four or five annular zones to provide the patient with 3.00 or 4.00 D of additional refractive power, respectively. And last but not least is the Lentis Mplus (Oculentis GmbH, Berlin; distributed by Topcon Europe, Rotterdam, Netherlands). This IOL may be a major breakthrough in multifocal IOL technology. Based on an innovative refractive principle, its sector-shaped near-vision segment is characterized by seamless transitions between the near and far vision zones. A multicenter study conducted under the leadership of Gerd U. Auffarth, MD, of Heidelberg University Eye Clinic, confirmed the high degree of patient satisfaction with less reflections and image jumps in twilight light conditions or in central headlight glare conditions as usually experienced with the currently available systems.
WHAT WILL THE FUTURE BRING?
As the number of people over the age of 65 years will increase significantly in the United States and in Europe over the next decade, eye surgeons across the globe will need to embrace the new accommodating and multifocal technologies. As in the United States, the penetration rate of these IOLs in Europe is still small, with no significant growth this past year. This is perhaps due to the worldwide economic situation, but also due to the skepticism of many eye surgeons. We need to learn to perfect the preoperative evaluation process and deal with a higher degree of expectations from our patients. Companies will deliver new concepts and refine existing accommodating and multifocal IOLs.
Our patients deserve to benefit from these exciting new technologies. In the following pages, Dr. Slade and I moderate a virtual roundtable discussion on IOL technologies, which we hope you will enjoy.
Erik L. Mertens, MD, FEBOphth, is Medical Director at Medipolis, Antwerp, Belgium and at FYEO Medical, Eersel, Netherlands. He currently serves as the Associate Chief Medical Editor of CRST Europe.Dr. Mertens states that he has no financial interest in the products or companies mentioned. He may be reached at tel: +32 3 828 29 49, e-mail: email@example.com.
- Wolff J. Presbyopia, myopia, astigmatism corrected with the Acri.LISA. Cataract and Refractive Surgery Today Europe. 2008;3(1):42-43.