AT THE WARING VISION INSTITUTE (WVI), when we evaluate new technologies—which we routinely do for surgical technologies — we always go through an objective process of evaluating beyond the FDA data. We want to understand how well these technologies work in terms of safety and efficacy in real-world use. Most importantly we want to think in terms of deciding which patients are the “sweet spot” for these different technologies.

With Vuity (pilocarpine 1.25%, Allergan/AbbVie), we now have the first eyedrop in history with FDA-approval for treatment of age-related blurry near vision (presbyopia). We’ve undertaken our objective process with this new technology and feel it will serve an important place in the market.

All new technologies have a risk/benefit and side effect profile, so it’s important that we look at these issues in a calculated manner.

It’s important to remember that the study required by the FDA study was a short-term, 30-day trial, so we did not have long-term data. Furthermore, the inclusion criteria included, but were not limited to, a limited range of refractive error of -4.00D to +1.00D with 2.00D of astigmatism without narrow angles or any retinal pathology that may predispose to retinal detachment. Fortunately there were no sight-threatening events noted in the FDA trial, so we have the data to evaluate how we roll this drop out in practice.

Patient Selection Matters

As with all treatment modalities, patient selection is imperative, and risk-benefit profiles need to be discussed and documented. We are excited to now have a new offering for a subset of patients for whom we did not previously have an offering — a pharmacologic agent for mild presbyopia.

At WVI, Vuity is serving as a treatment for the earliest stages of presbyopia and often as a bridge therapy. Sooner or later, the patient may not feel they’re getting enough benefit of effect, in which case we can move forward with discussing and evaluating the option of custom lens replacement as they move through the various stages of lens dysfunction.

Vuity is bringing in many new patients, some of whom perhaps had not been to an eye doctor in years or had possibly never been because they always had great vision. This gives us an opportunity to perform our advanced vision analysis for patients to make sure they’re getting the eye care they need.

The Sweet Spot for Vuity

In our practice, we’ve primarily maintained the FDA trial inclusion criteria in our rollout. What we have found is that the sweet spot for Vuity is the incipient or early plano presbyope, maybe in his or her mid-40s, still with excellent distance vision and still-functional reading vision but starting to notice the effects of presbyopia. And we have adopted this approach successfully in our practice, where historically we did not have another offering for these patients. These patients often had reading and distance vision that was too good for lens replacement and/or monovision LASIK. We now have this new and valuable offering in our practice, with which we’ve had great success.

We’ve also found success in other indications, for which we’ve not readily had a tool in the toolbox. One example is patients who had presbyopia-correcting lens implants but felt like they wanted a little bit better reading vision. Vuity has been a great tool for this. Furthermore, for those with presbyopia-correcting implants or other sources of dysphotopsia, Vuity has been a wonderful offering to improve these symptoms as well.

Vuity can be used in combination with contact lenses; however, it’s imperative that the drop is instilled 15 minutes prior to putting in a contact lens. This avoids encountering additional effects from the contact lens acting as a reservoir, which would apply to any side effects as well.

Talking to Patients

When we discuss Vuity with our patients, we carefully outline the risk/benefit ratio and the alternatives. One concern is retinal issues: retinal detachment has been described, so we provide retinal detachment precautions and also perform widefield fundus photography and macular optical coherence tomography after a dilated fundus exam to document the patient’s retinal health.

Because of that concern, we do not generally recommend Vuity for those with additional risk factors for retinal detachment, including peripheral retinal disease or having a longer axial length. This is particularly important for prior LASIK patients who are now presbyopic and who may have been high axial myopes prior to correction. Whether it was with LASIK or in a pseudophakic state with cataract surgery, we typically would not recommend Vuity due to the low, but present, risk of retinal detachment in patients who have a risk factor present for retinal detachment.

We also discuss the side effect profile with all of our patients. Those that have been reported include the sensation of feeling the eye focusing, accommodative spasm, distance vision being affected, and some eye redness, brow ache, and dimming of light. This dimming is due to the mechanism of action of Vuity, and has been what was expected, as stated in the formularies and on the label. It’s in the spectrum of noticing that there is some effect, but the vast majority of those who experience it feel that the benefit outweighs that potential side effect. However there is a small subset of patients in whom it may not make sense.

We recommend that all patients try Vuity at home prior to a normal functioning day to see how their body tolerates it, and we reassure them that the side effects tend to be short lived and improve with use over a week or two. And we let them know this is true of the function of their vision as well — it can also improve over 1-2 weeks.

Follow-up

We like to see patients back after 6 weeks to check on efficacy and side effects and to talk about alternatives if they’re having any issues. The overall feedback has been widely positive, and we’ve been encouraged to see patients calling and coming in for evaluations for age-related blurry near vision correction. This also creates an opportunity for us to see a large subset of patients who are in a more advanced stage of lens dysfunction, who may be better candidates for custom lens replacement, and it allows us to help these individuals in ways that may be more suitable.

My Personal Experience With the Drops

I have used the drop myself. I was actually one of the first commercial patients to try it in the United States. What I found is that, within 10 minutes, I was reading better, and it actually improved my distance vision as well. I had mild transient eye redness, and I could feel my eye focusing. The effect of the drop lasted for about 6.5-7 hours, during which it improved my reading and my distance vision with minimal side effects.

Patient Experience

For most patients, their experience mimics the FDA data and clinical trial results. They are getting about 6-7 hours of meaningful improvement from a single dose.

The vast majority of patients are experiencing a wow factor and have had a great experience with Vuity. There is a subset of patients in whom it perhaps does not provide enough benefit, or they are experiencing enough of the rare side effects that the benefit/side effect profile does not make sense for them to continue. But the nice thing is that patients have the opportunity to try it, and those for whom it doesn’t make sense can just stop using it. We have found that the efficacy seems to improve over 1-2 weeks of use, and the rare side effects seem to subside to a degree over that period as well.

Greater Customization Coming

It’s very encouraging that a number of companies are developing pharmacologic treatments for presbyopia. Vuity has paved the way and set the stage. There are at least 8 other treatments in the developmental pipeline, and as they arrive, we’ll be able to customize and tailor the different attributes to different patient types. ■

Dr. Waring is the founder and medical director of the Waring Vision Institute in Mt. Pleasant, SC.