Education, realistic expectations needed for presbyopia-correcting drops
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Vuity is our first FDA-approved pharmaceutical agent labeled for the treatment of a refractive error, presbyopia.
Vuity (pilocarpine hydrochloride ophthalmic solution 1.25%, Allergan) has now been on the market for 6 months. I would like to share a few personal learnings. I want to disclose that I consult widely in the field of refractive error correction including contact lenses, corneal and lens-based refractive surgery, and pharmaceuticals, including miotic drops and other topical agents for presbyopia and myopia.
First, presbyopia is another refractive error like myopia, hyperopia and astigmatism. Uncorrected, it represents a significant handicap and reduces visual performance and quality of life. The well-established methods of enhancing visual performance for all refractive errors include glasses, contact lenses and refractive surgery. Now, we also have a pharmaceutical option. Miotic drops enhance near vision in the emmetropic or distance corrected presbyopic patient by increasing depth of focus. This is the on-label indication for Vuity.
There are also many potential off-label uses. I have learned through years of practice that a miotic eye drop can correct low levels of myopia, hyperopia and astigmatism (less than 1 D), enhance visual performance in patients with a complex cornea and irregular astigmatism (for example, patients after incisional keratotomy or with mild keratoconus), reduce nighttime positive dysphotopsia for some phakic and pseudophakic patients, and enhance near vision in some patients after monofocal, extended depth of focus or presbyopia-correcting IOL implantation.
Like many other new product launches, the initial release of Vuity was accompanied by excess enthusiasm and irrational exuberance. We now realize that while small-diameter aperture optics as achieved by topical miotics can be a powerful tool for enhancing vision, they generate a result similar to only a +1 D to +1.5 D spectacle add. Miotic use is also associated with potential side effects and adverse events. Fortunately, the use of miotic drops to enhance vision is now entering the stage of reason and rational utility.
I believe every patient who uses a miotic drop to enhance their vision should be under the care of an eye care provider (ECP), either optometrist or ophthalmologist. The patient is best served when their care includes a comprehensive pretreatment eye examination with dilation and evaluation of the peripheral retina. They also benefit from counseling regarding the potential benefits, risks, adaptation and alternatives to miotic drop therapy. This is a prescription drop, not an over-the-counter eye whitener, and patients on miotic drops deserve a preoperative examination and follow-up care by an ECP. A significant secondary benefit of the release of Vuity is that many 40- to 55-year-old emmetropic presbyopes will have their first eye examination, and much treatable pathology will be discovered.
So far, most prescriptions are being written by comprehensive optometrists. Many comprehensive ophthalmologists who fit contact lenses and dispense eyeglasses will also find managing patients on Vuity attractive. The consultative ophthalmologist is unlikely to prioritize these patients, but over time, capturing 40- to 55-year-old presbyopes in the vision care system will prove laudable for patients, all eye doctors and society.
Second, side effects and adverse events are common and occasionally severe. The most common side effects are burning and stinging on instillation, headache or browache after instillation, a reduction in luminance resulting in difficulty with low-light environments and conjunctival hyperemia. Low-dose miotics used less frequently have fewer side effects and adverse events than higher-dose miotics used frequently. For most, miotics will be a lifestyle-enhancing eye drop used only intermittently.
The more severe adverse events include the possibility of posterior vitreous detachment with disabling floaters, vitreous hemorrhage, retinal tear or even retinal detachment. We know these severe complications are more frequent in axial myopes, especially male axial myopes with peripheral retinal degenerations such as lattice degeneration or a history of retinal tear. These patients are likely best served with other treatments for their presbyopia.
We have treated patients with miotic drops since Hardy and Gerrard discovered the agent in 1874, and the list of adverse events is well known and long, including allergy, iritis, cataract, induced myopic shift, pupillary block, iris cysts and reduced pupillary dilation after chronic use, and even systemic side effects such as nausea, vomiting, diarrhea, diaphoresis, bronchial asthma and cardiac arrythmia have been reported in susceptible individuals.
I believe presbyopia represents a significant handicap for many people. Most of us have become comfortable with offering contact lenses, with their myriad of side effects and adverse events, and even corneal or lens-based refractive surgery as an alternative to glasses in select patients with refractive errors after appropriate discussion of risks, benefits and alternatives. Miotic drops represent another therapeutic option for the patient motivated to reduce their dependence on glasses and enhance their visual performance.
Finally, it is important for the ECP and their patient to have realistic expectations about the benefits a miotic drop can provide. I conservatively think of a miotic drop as equivalent to a +1 D add. A +1 D add will seldom help the patient older than age 55 years. In several studies, about 50% of patients treated with a miotic drop gain three lines of near vision and 80% gain two lines of near vision. Most gain at least one line, but some get no benefit. That means there will be underresponders and even nonresponders who do not achieve enough visual improvement to be happy.
It is also important to know that some patient adaptation and learning regarding the vision enhancement and side effects of miotic drops are required. Patients often need to use these drops for 2 or more weeks to learn when they are most useful. A one-drop trial in the office is not adequate, and patients should be encouraged to try the drops in different settings and use them when most beneficial.
We have learned that a single aspirin tablet 30 to 60 minutes before applying a miotic drop can reduce the incidence of headache/browache and that over time this side effect becomes rare. For the patient who notices conjunctival hyperemia, a topical vasoconstrictor can mitigate this side effect.
Most patients will recognize the greatest benefit is in a bright-light environment. Miotic drops rarely enhance night vision except for the patient with disabling night vision symptoms.
Adequate patient counseling and educating our staff so they can help manage the expected phone calls from patients are important. Those that triage our calls must be on the lookout for potential sight-threatening adverse events such as a sudden onset of flashes, floaters or reduced side vision suggesting a posterior vitreous detachment, retinal tear or retinal detachment.
I believe that contact lenses, corneal refractive surgery and lens-based refractive surgery have helped millions of patients reduce their dependence on spectacles and enhance their visual performance. These methods have also been a positive for the practices that provide these services safely and effectively. Miotic drops to treat presbyopia and other refractive errors will be another visual performance-enhancing option that will benefit both patients and doctors. The proper utilization of glasses, contact lenses, refractive surgery and now eye drops to treat refractive errors requires the active participation of an ECP knowledgeable and skilled in the art.
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