In 2021, VUITY, a pilocarpine hydrochloride 1.25% ophthalmic solution (Allergan), received FDA approval and remains the only presbyopia-correcting eyedrop on the market in the United States. By stimulating pupillary constriction, VUITY is able to improve near vision and depth of focus through the principle of pinhole optics. Once-daily eyedrop dosage has been found to be safe and effective in improving near and intermediate visual acuity without significantly diminishing distance visual acuity in patients with mild to moderate presbyopia (GEMINI clinical trials).¹ In fact, the FDA recently approved a twice-daily dosing option for the VUITY, expanding its duration of effect for up to 9 hours (VIRGO clinical trials).²

While several surgical options exist to treat presbyopia, including monovision-based laser vision correction and custom lens replacement with presbyopia-correcting lenses, these procedures often require trade-offs, such as loss of depth perception and nighttime visual disturbances, respectively. For our cataract and refractive practice, VUITY has been a beneficial non-invasive option and a therapeutic bridge for presbyopic patients who are not yet ready for or interested in refractive surgery.

While presbyopia drops do not work effectively for every patient, we have found notable success through the following best practices regarding careful patient selection and counseling.

BACKGROUND

Before VUITY was made commercially available, our practice had been prescribing generic pilocarpine off-label for successful dysphotopsia management in certain patients with corneal higher order aberrations, including those with a history of radial keratotomy, keratoconus and corneal scars. Unfortunately, bothersome brow-aches and other unpleasant side effects made it difficult for those patients to continue treatment long-term.

We officially implemented VUITY at our practice in December 2021 and have observed remarkable improvement in many of our presbyopic patients’ near vision (by 3 lines or more on occasion as noted in the FDA trials) with better tolerability. Fortunately, none of our patients have experienced any serious adverse events such as retinal detachments or vitreofoveal traction, which have been reported in some rare cases.^3-5

PATIENT SELECTION

Motivation is key

The best candidate for VUITY is the motivated patient. This is the most important characteristic for patient selection, because these patients are more likely to utilize VUITY properly and consistently, allowing the patients to fully reap its benefits. This is especially important in the early stages of medication usage as some patients may experience a mild headache (the most commonly reported adverse event), which typically resolves after the first few days of use as mentioned in the FDA trials. Correspondingly, the best VUITY candidates will most likely be patients who stand to benefit the most in their quality of life due to its potential impact on their professional careers and/or their hobbies.

Consider several factors

It is important to remember that the response between each individual may vary depending on factors such as age, refractive error and baseline near vision. Other patient characteristics that may play a role in yielding greater efficacy (including baseline pupil size) are currently being investigated. Anecdotally, we have found that patients with larger baseline pupil sizes (photopic >3mm) may respond better to VUITY as a result of greater relative pupil constriction. Additionally, to date, there is no data supporting greater efficacy in blue-eyed vs brown-eyed patients.

Regarding age

Our practice has found greater satisfaction in younger (ages 40-50), nearly emmetropic patients, with early to moderate presbyopia as these patients still have good accommodative reserve and are more likely to achieve functional near vision (eg, J3 or better) and be able to see fine print on their phones and/or laptops. These patients also typically only need to dose VUITY on an “as needed” basis for specific occasions (eg, a night out at a restaurant) and can better tolerate an eyedrop regimen.

VUITY can also be a great adjunct to post-LASIK patients who believe their LASIK has “worn off” due to the onset of early presbyopia and who may consequently need a “boost” in their near vision prior to additional surgical considerations.

This does not mean, however, that VUITY should never be offered to moderate to advanced presbyopes who are starting further away from the finish line. On the contrary, it has been surprising how well the eyedrops have worked in some older patients with mild to moderate hyperopia and early lenticular changes who desire some visual improvement. Again, the most important criteria for patient selection is simply a highly motivated presbyopic patient who is willing to commit to a proper trial of presbyopia eyedrops.

Safety first

Besides patient eligibility, maximizing patient safety by excluding patients who may be at greater risk for developing adverse events is of the utmost importance. Since VUITY is a cholinergic agonist that works similarly to other miotics,⁶ it can cause anterior rotation of the ciliary processes, which can theoretically increase traction on the vitreous body and peripheral retina. Fortunately, the overall risk is very low and can be further reduced by performing a comprehensive dilated eye exam and excluding patients (especially myopes) with retinal holes, tears, lattice or other peripheral pathology that could predispose them to retinal detachment.

PATIENT EDUCATION AND COUNSELING

Define ‘success’

First and foremost, to achieve substantial success with presbyopia eyedrops, it is important to understand and explain what success may look like. While the VUITY clinical trial data showed that a significant portion of patients gained 3 lines or more of distance-corrected near vision, outcomes can vary greatly from one patient to another.

To help patients set realistic expectations, a near card or other visual aid can be utilized to help them visualize the difference a 3-line gain could make in their near vision (eg, from J7 to J2). At the same time, patients should be educated that presbyopia eyedrops will not perform at the same level of their reading glasses, which work partly through magnification, and that a successful outcome is simply achieving functional near vision (eg, J3 rather than J1+).

Explain the side effects

Patients should also be warned about potential side effects, including headache and hyperemia. Some patients may also complain about dim vision and therefore should be cautioned about driving at night if they are just starting to use the eyedrops. Of course, it is critical to inform patients about the possible onset of flashes, floaters, vision loss and/or sudden eye pain as “danger signs” that require immediate ophthalmologic attention. Additionally, it is important to encourage patients to adhere to the drops despite the presence of any common side effects as they frequently subside within the first few days of product use. Interestingly, the FDA clinical data found that the greatest number of patients achieved the maximum efficacy of VUITY at day 14. So, patients who stop using VUITY preemptively may forgo its optimal potential.

RECOMMENDED PROTOCOL

Based on the guidelines above, here is our practice’s current protocol for prescribing presbyopia drops that other centers can also consider adopting:

1. Scheduling consults/patient screening

For patients who contact us expressing specific interest in a presbyopia eyedrop such as VUITY, we advise them to book a comprehensive refractive eye exam with dilation to determine whether they would be a good candidate for the medication (usually at a fixed fee for the appointment).

2. The eye exam

For every presbyopia drop consult, we measure the patient’s uncorrected vision at distance and near, perform a manifest refraction and measure their best-corrected vision at distance and distance-corrected near vision. Unlike the uncorrected near visual acuity, the distance-corrected near visual acuity gives a better sense of the patient’s baseline level of presbyopia and provides guidance on managing patient expectations. For instance, a patient who reads no better than J16 with full refractive correction would be far less likely to achieve functional near vision with VUITY compared to someone who is able to read J5 with full distance correction.

On slit lamp examination, it is important to evaluate for the presence of uveitis, posterior synechiae and narrow angles, which could potentially be exacerbated by miotic eyedrops. A dilated fundus exam with careful evaluation of the peripheral retina for holes, tears and lattice is also an absolute prerequisite for prescribing VUITY in our practice.

3. Writing a prescription

With the recent approval of twice-a-day dosing for VUITY, it is now possible to write a prescription for a larger 5-mL bottle, allowing for greater cost savings for patients in comparison to two smaller 2.5-mL bottles. Our practice is also involved in an ongoing pilot program for which we are currently selling VUITY directly out of the office, which improves convenience and accessibility for our patients. This may eventually be made available to all practices nationwide.

4. Soliciting feedback and follow-up

We see our VUITY patients back after 1 month to assess their clinical response to the medication and to assess whether any additional education or guidance can be provided. After that, we typically see the patient back on an annual basis to repeat a dilated exam and to evaluate their candidacy for any surgical procedures.

CONCLUSION

Presbyopia eye drops, such as VUITY, can positively impact the quality of life for patients with presbyopia. Patient education and counseling, along with a comprehensive dilated exam prior to prescribing the eyedrops, is key to ensuring safe and efficacious outcomes for presbyopia correction. Our practice has implemented the aforementioned protocol with success, and we have noted a more profound benefit with the eyedrops in patients who are more motivated to adhere to the treatment regimen. As more presbyopia drops come to market (see “Future presbyopia-correcting drops”), establishing a reliable protocol for prescribing these medications will become even more essential to ensure patient safety and drug efficacy. OM

REFERENCES

1. Waring GO 4th, Price FW Jr, Wirta D, et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022;140(4):363-371.
2. Kannarr S, El-Harazi SM, Moshirfar M, Lievens C, Kim JL, Peace JH, Safyan E, Liu H, Zheng S, Robinson MR. Safety and Efficacy of Twice-Daily Pilocarpine HCl in Presbyopia: The Virgo Phase 3, Randomized, Double-Masked, Controlled Study. Am J Ophthalmol. 2023 May 5;253:189-200.
3. Eton EA, Zhao PY, Johnson MW, Rao RC, Huvard MJ. Rhegmatogenous Retinal Detachment Following Initiation of Pilocarpine Hydrochloride Ophthalmic Solution 1.25% for Treatment of Presbyopia [published online ahead of print, 2022 Aug 12]. Retin Cases Brief Rep. 2022;10.1097/ICB.0000000000001309.
4. Al-Khersan H, Flynn HW Jr, Townsend JH. Retinal Detachments Associated With Topical Pilocarpine Use for Presbyopia. Am J Ophthalmol. 2022;242:52-55.
5. Amarikwa L, Michalak SM, Caul S, Mruthyunjaya P, Rahimy E. Vitreofoveal Traction Associated With Pilocarpine for Presbyopia. Ophthalmic Surg Lasers Imaging Retina. 2022;53(7):410-411.
6. Allergan, an AbbVie Company. Highlights of Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf . Accessed June 29, 2023.

Shambhawi Thakur, MS, is a fourth-year medical student at the Eastern Virginia Medical School pursuing residency in ophthalmology. She is passionate about research, global health and mentorship, and she aims to provide quality eye care to her future patients in both local and global settings. She reports no relevant disclosures.

Dagny Zhu, MD, is a cornea, cataract and refractive surgeon currently practicing as medical director and partner at NVISION Eye Centers in Rowland Heights, Calif. Follow her @DZEyeMD on Instagram as well as on Twitter, Facebook, TikTok and LinkedIn. Relevant disclosures: Dr. Zhu is a consultant and speaker for Abbvie/Allergan and a consultant for Ocuphire and Visus.