The world of presbyopia management recently experienced an exciting development with the FDA’s approval of the first pharmaceutical treatment for presbyopia: VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% from Allergan. This eyedrop is a game-changer for both patients and doctors. Not only does the approval benefit patients in a broad sense, but it specifically helps the patient who has had or may be considering refractive surgery.

THE PRESBYOPE’S SURGICAL OPTIONS

The presbyopic patient seeking laser vision correction in the United States has traditionally had two choices: balanced distance vision in both eyes or monovision. If targeting distance vision correction in both eyes in this population, the patient will continue to need glasses for near activities. This may be unappealing for some patients and even deter them from proceeding with refractive surgery.

In our experience, many patients have never heard of monovision prior to their refractive surgery consultation. Not all patients tolerate it.¹ To determine tolerance in a patient who has not tried monovision in the past, a loose lens or contact lens trial is often used. Should the patient tolerate monovision well, they can enjoy minimal dependence on glasses after refractive surgery. Some of the patients who are most excited for laser vision correction are those with newly discovered monovision acceptance. These patients can’t wait to have improved distance and near vision.

Conversely, those who did not do well with a monovision trial sometimes feel disappointed and may even question the benefit of refractive surgery if they still need to use reading glasses.

‘A NEW WRINKLE’

The FDA approval of VUITY added a new wrinkle to the discussion on presbyopia management. This eyedrop has a broad indication for the treatment of presbyopia in adults.² It contains the active ingredient pilocarpine hydrochloride 1.25% and works by modulating pupil size to improve depth of focus.² With this improved depth of focus, patients can achieve improved intermediate and near vision.

In clinical trials of phakic patients ages 40-55, patients showed a statistically significant three-line or greater improvement in distance-corrected near visual acuity.² The medication is dosed once daily, and the improvement in near vision can be seen as soon as 15 minutes after dosing;² the effect has been shown to last up to 6 hours.² Additionally, improvement in distance-corrected intermediate visual acuity over the vehicle was shown to last up to 10 hours.² A study of the effectiveness of VUITY in pseudophakic patients is currently underway.

With the availability of VUITY, the preoperative refractive surgery conversation changes. Now the patient who does not tolerate monovision or does not have interest in monovision, still can have more freedom from near glasses with the use of this medication. Instead of, or in addition to a monovision trial, a VUITY trial can be utilized to help a patient understand how they can manage presbyopia after refractive surgery. Given improvement in near functionality with VUITY, patients can enjoy treatment options beyond just glasses and contact lenses. A patient who had decided against refractive surgery due to the continued need for presbyopia correction now may consider proceeding given the potential for pharmaceutical treatment.

HOW IT WORKS

While pilocarpine has been used in eye care for more than 100 years, traditional concerns have been ocular surface irritation and blurred vision. These are particularly problematic in the context of patients undergoing refractive surgery. All pilocarpine formulations are stored at low pH to maintain stability.^3-5 This acidic pH causes burning, stinging, and blurred vision when a drop is instilled into the eye.^3-5 Additionally, traditional formulations of pilocarpine have a highly viscous vehicle to extend the time the medication is on the ocular surface to maximize bioavailability.^3-5 This thicker vehicle also contributes to causing increased blur.

These unwanted symptoms are minimized with the improved formulation of VUITY. The drug is made with pHast technology, which enables the drop to equilibrate to physiologic pH within 1 minute of instillation.⁶ It improves the ocular bioavailability of the medication and allows for a once-daily dosing schedule compared to the need for more frequent dosing of previous formulations. Improved bioavailability also allows for the VUITY’s vehicle to be less viscous, minimizing visual blur and disruption to the ocular surface.⁶

Quick equilibration of pH as well as a less viscous vehicle improves the tolerability and comfort of VUITY compared to older formulations of pilocarpine.^3-6 This improved formulation allows the refractive surgeon more confidence in recommending this drop for patient consideration for the treatment of presbyopia after refractive surgery.

A START TO THE SURGERY CONVERSATION

We find that the approval of VUITY has not only been a benefit for the patients who were already seeking refractive surgery — it has been a refractive surgery conversation starter. The therapeutic is indicated for the treatment of presbyopia in adults, and this broad indication means even patients who need spectacle or contact lens correction can enjoy its potential benefits. Patients now come in for eye examinations seeking this medication to lessen their need for readers over their contact lenses or hold off transitioning into a bifocal. They can dose the medication, and as soon as 10 minutes later use their distance contact lenses.

As patients are experiencing improved visual function, conversations naturally flow into surgical options for reducing the need for distance vision correction as well. After prescribing VUITY, we coordinate an in-person or telehealth follow-up for these patients to continue the conversation about their vision correction needs and experiences. During this follow-up discussion, patients often share the excitement of specific examples of when not needing glasses was exciting and made a huge life impact — for example, shopping and seeing price tags, reading a cell phone or reading a menu.

These experiences often start a patient thinking about other times when they would like to not rely on glasses or contact lenses, like swimming, traveling or exercising. As the patient starts evaluating the life benefits of less reliance on glasses and contact lenses, refractive surgery becomes a more serious consideration.

WHEN LASIK ‘WEARS OFF’

Lastly, VUITY is a great treatment option to offer the patient who states “My LASIK wore off” due to now experiencing presbyopia. These patients invested in themselves to improve their vision and have enjoyed the freedom from glasses they gained with refractive surgery. As their near vision worsens, they can feel frustrated by the prospect of returning to eyeglasses.

In our experience, the ability to consider the use of an eyedrop vs only glasses or contact lenses has been very appealing to these patients, enabling them to maintain as much spectacle independence as possible. This conversation often starts with education regarding what presbyopia is and why after many years of spectacle independence the patient is now dealing with a need for refractive correction.

Prior to the approval of VUITY, patients’ choices included glasses, contact lenses, or potential monovision refractive surgical correction if appropriate, or refractive lens exchange. All of these choices are still discussed, but adding a pharmaceutical treatment allowing for non-surgical continued independence from glasses and contact lenses, even if just for some specific activities, feels good for both the patient and the doctor to help the patient maintain their lifestyle.

Future studies will provide more information on the potential benefit in the pseudophakic population.

ABOUT SIDE EFFECTS …

Patients should be made aware of the side effects of VUITY, which Allergan reports are minimal. Headache and conjunctival hyperemia were the most common adverse reactions reported greater than 5% of the time in patients in the GEMINI I and GEMINI II studies.² Blurred vision, eye pain, increased lacrimation and eye irritation were reported in 1-5% of patients.² The contraindication for use of VUITY: patients with a known hypersensitivity to the active or inactive ingredients; the drug also is not recommended for use in the presence of iritis for the concern of developing posterior synechiae.² Given that VUITY causes miosis, patients should be advised to exercise caution in poor illumination.² Additionally, rare incidents of retinal detachments have occurred with use of miotic medications in susceptible individuals and those with pre-existing retinal pathology.⁷ No cases of retinal detachment were reported in the clinical trials for VUITY.²

EXPANDED OPTIONS, EASIER CONVERSATIONS

The approval of the first pharmaceutical treatment for presbyopia marks an exciting time for ophthalmology. Discussions about visual expectations in this patient population as well as the pre-presbyopic population are evolving, so at last we can offer them more than a one- or two-size-fits-all approach.

This new paradigm also fits easily into the conversations with patients considering refractive surgery. In our experience, this advancement in presbyopia correction has not only helped patients who have had refractive surgery or are currently seeking refractive surgery by enhancing near visual function, but it has also opened the minds of patients who have not previously considered refractive surgery. OM

REFERENCES

1. Jain S, Arora I, Azar DT. Success of monovision in presbyopes: Review of the literature and potential applications to refractive surgery. Surv Ophthalmol. 1996;40:491-499.
2. VUITY prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf . Accessed Feb. 22, 2022.
3. Jain N, Verma A, Jain N. Formulation and investigation of pilocarpine hydrochloride niosomal gels for the treatment of glaucoma: intraocular pressure measurement in white albino rabbits. Drug Deliv. 2020;27:888-899. https://tinyurl.com/m383rabr . Accessed Mar. 28, 2022.
4. Mitra AK, Mikkelson TJ. Mechanism of transcorneal permeation of pilocarpine. J Pharmaceutical Sci. 1988;77:771-775.
5. Anderson RA, Cowle JB. Influence of pH on the effect of pilocarpine on aqueous dynamics. Br J Ophthalmol. 1968;52:607-611.
6. Giyanani J, Shabaik Y, Penzner J, Gore A. Novel, fast-equilibrating, ophthalmic vehicle for enhanced patient comfort and tolerability for pilocarpine delivery. PharmSci360. Oct. 26-Nov. 5, 2020. https://tinyurl.com/4a27ybay . Accessed Jan. 21, 2022.
7. Puustjarvi T. Retinal detachment during glaucoma therapy. Review. A case report of an occurrence of retinal detachment after using membranous pilocarpine delivery system (Pilokarpin lamellar (Ocusert) 11 mg). Ophthalmologica. 1985;190:40-44.

Ralph Chu, MD, is the founder and director of Chu Vision Institute in Bloomington, Minn. His specialty areas include cataract, refractive, cornea and minimally invasive glaucoma surgeries. Disclosure: Dr. Chu is a consultant to Abbvie.

Jessica Heckman, OD, is the vice president of Clinical Affairs at Chu Vision Institute, Bloomington, Minn. She specializes in the care of patients with cataract, glaucoma, refractive surgery and corneal conditions. Dr. Heckman has participated as a sub-investigator in more than 30 FDA clinical trials. Dr. Heckman reports no relevant financial relationships.