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Growth in premium IOLs represents opportunity for ophthalmology
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The so-called premium channel for IOL implants includes presbyopia-correcting IOLs, toric monofocal IOLs and toric presbyopia-correcting IOLs. With the recent approval of the Abbott Symfony IOL, we now have three categories of presbyopia-correcting IOLs: multifocal, accommodating and extended depth of focus. While each of these IOL categories is commonly used for symmetrical bilateral implantation, the lenses can also be custom mixed with one style implant in one eye and another in the fellow eye. There are many multifocal IOLs approved in the U.S., with adds ranging from a low of +2.5 D to a high of +4 D. Most surgeons are finding the lower add multifocals between +2.5 D to +3.25 D to be preferred by patients because they provide better intermediate vision and cause less night vision disturbances such as glare, starburst and halo.
The multifocals approved in the U.S. all use diffractive optics and in reality are bifocals, with two zones of focus. In Europe and many Asian countries, trifocal diffractive multifocal IOLs with three overlapping zones of focus have replaced bifocal diffractive multifocal IOLs. Surgeons and patients find a more seamless range of vision from far to near with these trifocal IOLs, with similar reduced contrast and night vision symptoms as that found in bifocal IOLs. Unfortunately, we do not have a trifocal or even toric bifocal multifocal IOL approved in the U.S. as yet, limiting intraoperative astigmatism management to corneal relaxing incisions and primary incision construction and placement.
All studies confirm that a critical component to generate high patient satisfaction is achieving a refractive outcome near plano. The uncorrected quality of vision and patient satisfaction generated by a diffractive multifocal IOL is especially sensitive to residual astigmatism. Patient satisfaction declines with as little as 0.5 D of residual sphere or cylinder and is measurable at 0.25 D, so good refractive cataract surgery skills and a good postoperative enhancement strategy, usually laser refractive surgery, are required to achieve the best outcomes. I personally am very aggressive in offering enhancements to my premium IOL patients and always target a final outcome of less than 0.5 D of residual spherical equivalent and cylinder. I have found that long-term patient satisfaction and word-of-mouth referral are highly correlated with achieving a refractive target near plano. Quality biometry, intraoperative aberrometry if available, and a PRK or LASIK enhancement in 10% to 15% of patients is one formula for success.
Our one approved accommodating IOL, the Crystalens (Bausch + Lomb), is available in aspheric and toric aspheric versions. I have used this IOL in select patients for more than a decade and find that for me it does increase depth of focus approximately 1 D in the average patient. It therefore gives excellent distance and intermediate vision with fewer quality of vision issues. To get good near, I find that I need to target slight myopia in one eye, usually –0.75 D to –1 D, and it is necessary to manage the occasional capsular contraction/Z syndrome with an early YAG laser capsulotomy. Some patients with lower than average depth of focus need to have the near eye myopia increased to –1.5 D to –2 D as in standard monovision to achieve good near vision. I have found the Crystalens to be excellent for patients with prior radial keratotomy and early-generation PRK/LASIK patients in whom there is significant higher-order aberrations rendering a multifocal IOL inappropriate.
I have just started to implant our first extended depth of focus (EDOF) IOL, the Symfony. Through correction of chromatic aberration, quality of vision is similar to a monofocal IOL, and night vision disturbances are reduced but, in my experience, not absent. My clinical impression is that this IOL is giving about 1.5 D of increased depth of focus, slightly more than the Crystalens. Distance and intermediate vision are excellent, and near is functional but less than that achieved with a higher add power multifocal IOL.
Strategies to improve near vision with the Symfony include achieving a postoperative refraction, with very mild bilateral myopia with a –0.125 D to –0.25 D target in both eyes, and taking advantage of bilateral summation or targeting plano in one eye and –0.375 D to –0.75 D in the other with a mini-monovision strategy. Both approaches appear to generate high patient satisfaction and vision in the 20/25 or better range from far to near.
This is the first premium IOL approved in the U.S. with both an aspheric and toric aspheric version from day 1 of launch, and this is an unexpected but welcome regulatory outcome. It will be interesting to see if the addition of the lower-powered diffractive multifocal IOLs and newly arrived EDOF Symfony in the U.S. grow the presbyopia correction IOL market.
The market share of presbyopia-correcting IOLs has been stagnant for nearly a decade, at approximately 5% of all implants. Meanwhile, toric IOLs, which were approved later, have continued to grow, approaching 10% market share. Probably we will now need to follow three categories: toric, presbyopia-correcting and toric presbyopia-correcting.
I have participated on many panels trying to predict the eventual nationwide penetration of premium channel IOLs, and the consensus repeatedly reached is 30% to 35% of all IOLs implanted. Total IOLs implanted in the U.S. are approaching 4 million per year, growing at approximately 3% to 3.5% per year. If the premium channel doubles from approximately 15% to 30% of IOLs in the U.S. over the next 10 years, that will be a 6% to 7% growth rate, or double the growth of the overall market. In addition, the revenues generated per premium IOL implanted are significantly higher than with a monofocal IOL for both the surgeon and the manufacturer.
Surveys suggest that about 80% of U.S. surgeons are implanting premium IOLs today, and this will likely grow to 95%-plus in the next decade. This growth in revenues represents a great opportunity for ophthalmology, and we can expect continuing strong investment and innovation in this area. In the years to come we can expect more toric monofocal and presbyopia-correcting IOL offerings, including aspheric and toric aspheric trifocals and additional EDOF lenses, to gain regulatory approval. Less certain and more challenging to develop, but still attracting significant investment, are additions to the accommodating IOL marketplace.
Offering a premium IOL option to all patients who present for cataract surgery in the U.S. today is in my opinion a preferred practice pattern for all cataract surgeons, as is acquiring the skills required to generate a refractive outcome near plano, ensuring a highly satisfied patient.
Disclosure: Lindstrom reports he is a consultant and investor in Abbott Medical Optics and Bausch + Lomb.