Demand will continue to grow for pharmacologic, lens-based presbyopia treatments
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Presbyopia is the second most common refractive error we deal with as ophthalmologists, myopia being No. 1. Approximately 128 million people in the United States and 2 billion people globally have presbyopia.
Most individuals manage their presbyopia with optical correction, using spectacles and/or contact lenses. Presbyopia-correcting bifocal, trifocal and progressive add glasses along with monovision and multifocal contact lenses are important products financially in the optical world, and significant investment is directed toward both to catalyze innovation.
Like every other refractive error, uncorrected presbyopia represents a handicap in daily activities and reduces quality of life. While most patients do well with glasses and/or contact lenses, there is significant demand for alternatives to reduce dependence on optical correction. The three primary alternative treatments today are presbyopia-correcting eye drops, refractive corneal surgery and refractive lens-based surgery. This is an area of significant personal interest, and I have worked with multiple companies over 4 decades supporting innovation in this field. My current disclosures are listed below.
First, a few thoughts on the pharmacologic correction of presbyopia. Our first FDA-approved eye drop for presbyopia, Vuity (Allergan), was launched a year ago. Vuity, which is 1.25% pilocarpine in a proprietary vehicle designed to reduce discomfort on instillation, initially experienced rapid growth in prescription volume. Unexpectedly, Vuity was widely prescribed to many without an eye examination and proper patient counseling. This resulted in a number of dissatisfied patients, and of greater concern, some users experienced adverse events, including a few that were sight-threatening, such as retinal tear or detachment.
We have experienced this irrational exuberance with a new drug or device before and now appreciate that 1.25% pilocarpine is a prescription eye drop, not an over-the-counter eye whitener. Vuity usage is better managed if an eye care professional is involved with an appropriate eye examination and patient counseling regarding risks, benefits, alternatives and appropriate education regarding its use, with available post-prescription patient support.
Of interest, this is the first prescription product in which the majority of prescriptions were written by optometrists rather than ophthalmologists. This was expected, as optometry manages approximately 70% of patients seeking optical correction for refractive errors, and the numbers I have seen suggest that optometry has written just more than 70% of Vuity prescriptions and ophthalmology slightly less than 30%. This is an interesting finding, as we have another pharmaceutical for the treatment of a refractive error pursuing FDA approval in 2023, low-dose atropine for the management of progressive myopia. I expect optometry to be the major prescriber of low-dose atropine as well, as it is actively engaged in the management of progressive myopia.
In an earlier stage of development is another eye drop that shows promise to induce corneal cross-linking and help manage progressive keratoconus. These three drops represent a new vertical in eye care, the pharmacologic treatment of refractive errors, which I expect to evolve over the next decade into a significant category with multibillion-dollar potential. The Vuity launch suggests that the eye care professionals who will cater most to patients seeking a pharmacologic treatment for their refractive error will be our optometric colleagues, but many of them will work side by side with their ophthalmologist colleagues in an integrated eye care delivery model.
Unfortunately, Novartis recently announced that it will not continue development of alpha-lipoic acid eye drops for the treatment of presbyopia, but significant investment continues by multiple precommercial companies developing alternatives to Vuity. After a rocky start, I remain optimistic that the utilization of miotic eye drops to enhance near vision, and for some patients distance vision as well, will find a meaningful role in eye care.
The second potential alternative to glasses and contact lenses for managing presbyopia is refractive corneal surgery. This arena of innovation attracted significant financial and human capital over the past 4 decades but has suffered multiple failures during development and following commercialization. Approaches that have failed to achieve FDA approval include excimer laser presbyLASIK, various forms of scleral surgery including scleral compression, scleral expansion and scleral incisions, and corneal surgery with excimer, holmium or femtosecond lasers. Even those surgical procedures that have achieved FDA approval, such as conductive keratoplasty and the Kamra corneal inlay (CorneaGen), have failed in the marketplace.
A major learning is that the presbyope, especially the emmetropic presbyope, is demanding and extremely risk averse. Monovision remains a useful approach but in most cases is utilized in treating presbyopia in patients who also manifest significant hyperopia, myopia and/or astigmatism. This leads me to refractive lens-based surgery, which is demonstrating significant growth.
The continuing evolution of phacoemulsification with advances in safety and efficacy along with adjuncts such as femtosecond laser-assisted cataract surgery and improved optics in our presbyopia- and astigmatism-correcting IOLs have led many surgeons and their patients to favor refractive lens-based surgery. For the presbyopia patient with hyperopia or hyperopia and astigmatism, the risk-benefit ratio is especially attractive, and patient satisfaction is high with refractive lens exchange. Refractive lens exchange for presbyopia in low to moderate myopes with or without astigmatism is also growing in popularity.
Patient satisfaction for even the risk-averse emmetrope is high once presbyopia becomes a significant handicap, and many of these patients also experience improved quality of distance vision as their aging natural lens is replaced. The high myope with increased axial length remains a challenge because of the risk for retinal tear or detachment. Lens-based surgery in the axial myope is usually delayed until they develop a visually significant cataract, but cataracts present in the axial myope at an earlier age.
As I look ahead, I expect refractive corneal surgery to be reserved for the younger pre-presbyopia patient. I project strong growth for both pharmacologic treatment and the use of refractive lens-based surgery for the presbyopia patient. There will be meaningful patient demand for both, which will catalyze investment, innovation and continuing improvement in the treatments available.
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