By Michael Lachman
The cataract surgery premium channel consists primarily of presbyopia-correcting intraocular lenses (PC-IOLs), toric IOLs that correct astigmatism, and femtosecond-laser assisted cataract surgery (FLACS). This market represents a classic glass half-empty, glass half-full scenario: It is an underpenetrated market that invites constant examination of the barriers that have limited adoption to date, and at the same time it represents the fastest growing segment of the cataract market with tremendous upside potential. Elizabeth Yeu, MD, of Virginia Eye Consultants led a panel discussion that explored both the barriers and drivers that define this market.
According to Market Scope, penetration of PC-IOLs in the US market has remained in the range of 4% to 5% of cataract procedures since 2008. Results of the 2015 ASCRS Clinical Survey suggest that the leading barrier to PC-IOL adoption is cost to the patient, followed by concern over nighttime quality of vision. Toric IOLs have accounted for only 6% to 8% of cataract procedures since 2010, even though approximately 52% to 70% of cataract patients have enough astigmatism to qualify for these lenses.
Since 2005, reimbursement policy in the US has allowed Medicare cataract patients to pay an additional amount for premium/refractive IOLs that address either presbyopia or astigmatism. While similar policies exist in some international markets, in many countries patients who choose premium IOLs must pay for the entire cataract procedure at private-pay facilities, foregoing government-based reimbursement. Driven in part by this favorable payment policy, the total premium IOL penetration today in the US of about 13% compares favorably to the penetration rates of 8% in Western Europe and 9% in Japan.
FLACS represents the newest segment within the premium channel. Although the pace of laser placements has slowed, FLACS procedure penetration has grown steadily over the past four years, reaching nearly 10% of US cataract procedures by the end of 2015, according to Market Scope.
Panelists at the OIS session weighed in on the barriers to adoption of FLACS. Sherman Reeves, MD, noted that a key barrier today is “that it’s not clearly clinically better.” David Chang, MD, added, “In terms of barriers, looking globally, the adoption correlates with the freedom in a given economic system to bill the patient for the cost.”
Denise Visco, MD, commented that FLACS technology will not improve clinical outcomes for adopting surgeons “until they learn how to use it. It’s really a very intensive learning process to go from a blue collar, basic cataract practice to a refractive cataract practice.” Eric Donnenfeld, MD, pointed out that it’s the average cataract surgeons, not the most expert surgeons, who are seeing the greatest improvement in refractive results and complication rates with FLACS. “Raising the level of quality for every surgeon in the world – not just making great surgeons better – is our goal.”
The 2015 ASCRS Clinical Survey provides an optimistic data point for FLACS: 94% of respondents believe that they will adopt the technology within the next 10 years.
Speakers from four companies that develop and market premium cataract products provided their perspectives on the category.
The KAMRA small-aperture corneal inlay from AcuFocus was approved by the FDA in April 2015 for the treatment of presbyopia, and the company began a controlled commercial launch in June. Nicholas Tarantino, OD, chief clinical and regulatory officer of AcuFocus, said that the US rollout has exceeded every internal company metric. During the first year in the US, over 2,000 inlays have been implanted, and over 80% of implanting surgeons have reordered, typically within one month. The heavy focus on surgeon training has resulted in excellent clinical outcomes since launch, with mean uncorrected distance and near visual acuity of 20/25 and J2, respectively. Refractive practices that have advertised the KAMRA inlay have also experienced over 20% average growth in LASIK and premium IOLs, demonstrating a significant pull-through effect from marketing a presbyopia solution.
AcuFocus has also incorporated its small-aperture technology into the IC-8 presbyopia-correcting IOL, which has been under investigation in Europe and is entering a commercial launch phase. The IC-8 IOL provides extended depth-of-focus while maintaining high image quality and avoiding the glare and halos typically associated with multifocal IOLs. The small-aperture optic is also capable of correcting up to 1.50 D of astigmatism, potentially addressing over 80% of cataract patients, without the need for a toric IOL or astigmatism-correcting corneal incisions.
Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals company, remains the only firm with an FDA-approved accommodating IOL, the Crystalens AO. Andrew Chang, general manager and senior vice president of Bausch + Lomb US Surgical, highlighted clinical data from a study of long-term quality of vision and patient satisfaction with accommodating and multifocal IOLs conducted by John Hovanesian, MD. In this study of 117 patients, nearly three times as many Crystalens patients as multifocal IOL patients (44% vs. 16%) reported complete absence of glare and halos. This suggests that the accommodating IOL delivers better overall quality of vision and results in fewer problems with night driving.
At OIS@ASCRS, B+L announced a collaborationwith IBM to develop an app for cataract surgeons that will be available on Apple’s iPhone and iPad and will have applications beyond just the premium channel. The app will help surgeons streamline their workflow and plan surgical interventions by delivering patient information and IOL options on a single, digital platform at the point of care. Patient information could include IOL calculations, corneal topography, historical surgical data, lifestyle preferences, and personalized IOL options. The app, which IBM will develop as part of its MobileFirst for iOS partnership with Apple, is expected to begin pilot testing later this year.
Abbott Medical Optics
Over the past year, Abbott Medical Optics (AMO) has established a leading share position in the US PC-IOL market, driven by the new low-add-power Tecnis Multifocal IOLs. Outside the US, the early success of the Tecnis Symfony Extended Range of Vision IOL has also contributed to market share gains. On July 15, the Tecnis Symfony IOL became the first FDA-approved extended depth-of-focus IOL, based on results of a 298-patient US pivotal study. The FDA approval also included four toric models for correction of astigmatism.
Leonard Borrmann, divisional vice president of R&D for AMO, noted that Abbott’s approach across the Tecnis Multifocal family is to provide a range of IOL options to meet diverse patient needs, delivering high-quality vision (20/25 or better) throughout the full range of distance, intermediate, and near. With respect to enhanced functionality for patients, the low-add-power Tecnis Multifocal +2.75 D IOL delivers full and partial spectacle independence in 61% and 38% of patients, respectively. More than 90% of patients with this lens report no difficulty with night vision, similar to a Tecnis monofocal IOL, and 97% of patients report that they would choose to have the same IOL again. Beyond improving multifocal IOL technology, Abbott is also working to expand the premium channel through surgeon training and education, patient awareness programs, and creation of new premium IOL categories, such as extended range of vision.
Michael Onuscheck, global surgical franchise head for Alcon, a Novartis company, outlined the firm’s approach to innovation within the premium channel, which involves both internal development and external partnerships and acquisitions. In this decade, the focus of cataract innovation has shifted from safety, efficacy, and efficiency/throughput to refractive outcomes and meeting patients’ expectations with respect to vision and independence. Alcon has recently launched the UltraSert pre-loaded IOL system globally and the PanOptix trifocal IOL outside the US. The company is also looking at extended depth-of-focus (EDOF) technology and is developing next-generation IOL platforms and materials. In April, Alcon announced a strategic alliance with PowerVision, Inc. Alcon’s investment in PowerVision will fund further development of the company’s FluidVision fluid-based accommodating IOL technology, and will provide Alcon the option to acquire the company. Alcon also has a relationship with ClarVista Medical, which is developing a modular IOL platform.
Alcon has been very active on the M&A front in recent years, having acquired a number of technologies that are now part of the company’s Cataract Refractive Suite, including the LenSx femtosecond laser, ORA intraoperative aberrometry system, Verion image guided system, and Luxor ophthalmic microscope. The focus going forward will be on integrating the full suite in order to improve simplicity and ease-of-use for the clinician.
Elizabeth Yeu, MD
Dr. Yeu received her Doctorate of Medicine in undergraduate studies and medical school program at University of Florida College of Medicine in 2003.
David Chang, MD
David F. Chang, MD is a graduate of Harvard College and Medical School, and completed his residency at UCSF where he is now clinical professor.
Eric Donnenfeld, MD
Dr. Donnenfeld is a Clinical Professor of Ophthalmology at NYU, Trustee of Dartmouth Medical School, and founding partner of Ophthalmic Consultants of Long Island.
Sherman Reeves, MD, MPH
Sherman W. Reeves, MD, MPH is a board certified ophthalmologist with subspecialty training in cornea and refractive surgery.
Denise Visco, MD
Denise M. Visco, M.D. is Medical Director and founder of Eyes of York. Dr. Visco is a pioneer of cataract surgical advancement being the first female surgeon in the world to perform cataract surgery with the LENSAR Advanced Laser Cataract System.
Nicholas Tarantino, OD
Nick Tarantino, OD is Chief Clinical and Regulatory Officer and Head of R&D for AcuFocus, Inc., a company specializing in innovative solutions for the treatment of presbyopia.
Andrew is the General Manager and Vice President of US Surgical for Bausch + Lomb, a subsidiary of Valeant International.