Varied Views on VUITY

In late October 2021, following two Phase III clinical studies – GEMINI 1 and GEMINI 2 (1, 2) – that showed improvement in intermediate vision and no impact on distance vision of presbyopic patients for up to six hours after instillation, the FDA approved the first-ever eye drop developed to treat presbyopia: pilocarpine HCI ophthalmic solution 1.25%, better known as VUITY (3).

In December 2021, the manufacturer of VUITY, Allergan, an AbbVie company, announced that the eye drop was available – if prescribed – in pharmacies across the US.

Have US-based specialists decided to prescribe it to their patients? What have their impressions and experiences been like, and – more importantly – how have their patients reacted? What do their colleagues from other parts of the world think – are they eagerly awaiting approvals in their countries or regions and will they decide to make use of VUITY when available – or are they ambivalent?

We invited world renowned specialists to share their perspectives.

Is the approval of VUITY a big ophthalmology milestone? 

Arthur Cummings: I think it is! For the first time, the general population will get to hear that you can improve reading vision without the use of reading glasses. This will drive patients seeking the new miracle drop to ophthalmologists and optometrists. It will work for some, and they will return to the practice one day for surgical solutions when the drops are no longer sufficient, or they are tired of using them. Those it doesn’t not work for, will learn about surgical alternatives such as blended vision laser vision correction or refractive lens exchange and custom lens replacement with trifocal and EDoF IOLs. Bottom line: VUITY and similar drops are going to create awareness of presbyopia like nothing has done before.

David Goldman: In a sense, this is a very big milestone. In the past we’ve only had invasive techniques to combat presbyopia such as specialized contact lenses or corneal inlays. Now, we have the opportunity to correct presbyopia in a pharmacologic fashion, but with a reversible application.

Kjell Gunnar Gundersen: In my opinion, it is not a milestone, and the approval means close to nothing to our profession.

Guy Kezirian: Presbyopia treatments represent a new market space that will expand rapidly. It is important to view this new market correctly. Applying “market share” mentality to this area is misguided. By market share mentality I mean looking at the market as a fixed size and competing over which product or approach captures the largest share at the expense of others, similar to cutting a fixed pie and apportioning it among hungry diners. This approach does not apply to the presby market. It is a “market growth” opportunity where new entries will grow the market and speed adoption, benefitting all participants. As they enter the market, the pie will grow.

Florian Kretz: In my opinion, the approval of VUITY is not a milestone. The concept of pilocarpine as a biotic agent has been known for a long time. In lower concentrations we used it to treat dysphotopsia after LASIK or diffractive IOL implantation. Latest models of pinhole implants like Karma or on IOL base like IC-8 or the Morchel add-on show good results. Still – subjectively – patients do complain about loss of visual field even it is not measurable. Also, German driving law does not allow patients after miotic or mydriatic drops to operate a car at night. Nevertheless, as soon as VUITY makes it across the Atlantic, it will be an option to help patients cope with presbyopia and cover for residual refractive errors. 

Ben LaHood: I do not see the FDA approval of VUITY as a big ophthalmology milestone as I do not see VUITY as being as revolutionary as the introduction of intraocular lenses, phacoemulsification, OCT imaging, or even, more recently, MIGS devices. We have known about the potential side effects of pilocarpine (both good and bad) for a long time and these effects are what VUITY is harnessing. I would count trifocal IOLs and the extended range of focus optical design of Vivity as being more revolutionary in the management of presbyopia. A major milestone in the pharmacological treatment of presbyopia will come when we can soften the crystalline lens and enhance ciliary muscle function rather than causing miosis.

Robert Osher: The approval of a reversable pharmaceutical treatment of presbyopia is very promising. Patients in their forties have always sought options beyond the age-defining reading glasses to restore their near vision and maintain their youthful active lifestyle. With this first, as well as the expected future approvals, we have the potential to help these patients and address their visual needs and desires.

Ray Radford: I don’t see it as anything new, but rather as using old knowledge for a purely marketing exercise to sell a product. After all, the pinhole effect has been known for so long!

Vance Thompson: I believe the approval of VUITY is huge for ophthalmology, optometry, eyecare in general, and mankind. Presbyopes are notorious for not having had their eyes examined for years. And then when near leaves them, many just go get a pair of reading glasses and still do not get their eyes examined. Now that they are hearing about VUITY drops, they are calling us and we are suggesting a quality eye exam, not unlike a refractive consult, to make sure their eyes are healthy, they are good candidates for presbyopia drops, and we are planting the seed about surgical options to help their presbyopia journey if the drops do not serve all their needs in the near or long term. These drops are great for presbyopes, but also our profession.

Blake Williamson: This approval has created a new category, putting presbyopia on the map. Right now, many people outside of ophthalmology don’t consider dysfunctional lens syndrome or presbyopia a disease, but through direct consumer marketing, the general public will find out what presbyopia is. It’s going to be seen for what it is: a disease of aging and unconditional loss of vision.

To those who say that “it’s just pilocarpine,” I say that the vehicle used in the drop changes into a more physiological PH than in other solutions within a couple of minutes, resulting in better penetration of the cornea and less discomfort for the patient. This formulation offers great bioavailability.

Have you prescribed VUITY to any of your patients or will you in the future?

Arthur Cummings: Unfortunately, VUITY is not available in Ireland yet. When it does receive approval, I will be making it available to my patients and prospective patients. I don’t know of a better educational tool for presbyopes to illustrate the benefits of being able to see up close without reaching for glasses first. If you want to grow your refractive practice, you need to offer VUITY or similar drops when they are approved.

David Goldman: I have already begun prescribing VUITY for patients. Many patients specifically called in wanting to try it after they heard about it in the news.

Kjell Gunnar Gundersen: It is not yet available in Norway, where I practice, but I have no plans to prescribe it to my patients when it is approved here.

Florian Kretz: VUITY is another option we will have available. I would love the drug to be labelled also for residual refractive errors.

Ben LaHood: VUITY is not currently approved for prescription in Australia although it appears it will be in the near future. One of the most difficult groups of patients to manage as a refractive surgeon are early presbyopes. Current surgical options are not ideal for these patients who are beginning to struggle with the limitations of their reduced near vision. I can see that for these patients, VUITY will offer a temporizing treatment, and I will likely prescribe it for these patients.

In Australia, I am already regularly being asked by my refractive surgery patients about VUITY, so interest is certainly building.

Ray Radford: I would only say: use a bright light on the page! Natural miosis with convergence and reading is a real process and part of the accommodation convergence reflex – a physiological response. I worry that using these drops will become a real issue for night vision. Elderly patients often naturally have very small daytime pupils and adaptation from light to dark areas may be affected. Using the drops might affect physiological pupil enlargement.

I advise my patients to avoid unnecessary expense and potential side effects such as headaches or red eye.

Vance Thompson: We are getting lots of phone calls about the VUITY drop. We are asking patients who their eye care provider is and when they had their last exam. We are emphasizing the importance of an exam first. If possible, we are coordinating their care to see the doctor they have trusted for years. We are also asking them about their distance vision and their night time image quality. If they are blurry at a distance and their night time image vision quality is reduced, we suggest they see us, since they may have a surgical issue already. If they have a great exam and refractive consult and would like the drops, we prescribe them. We are handling different situations differently. This means we are educating our phone team and the whole team on what the approval of this drop means to eyecare and how we should handle patient questions and dive deeper to be our best for each individual.

Blake Williamson: I used the drops for a patient in the same week they were commercially available in the US, and have used them for several patients since then. It is a fantastic tool for patients in their 40s and 50s with presbyopia that allows them to reduce or even eliminate the need for reading glasses. More than the drop itself, I love the mindset shift it’s going to create in our patients to let them know that there’s something to address longsightedness other than reading glasses.

In what situations do you recommend VUITY or advise against it? 

Arthur Cummings: I’d recommend it to early presbyopes, patients with previous laser vision correction that are becoming presbyopic or where their blended vision has run out of road, like a -1 D target – it should provide reading vision to 52 years of age or thereabouts. When this happens, VUITY may be an excellent bridge to enhance reading vision until they are ready for IOL surgery.

I would be careful with previous high myopes as pilocarpine has been seen to add to the risk of retinal detachment in high myopes.

David Goldman: Based on the clinical trials, I would still prescribe it to the older pseudophakic patients in my practice, but with a warning that it may not provide as much benefit. 

Kjell Gunnar Gundersen: There are no situations where I can see it as worth prescribing to patients.

Florian Kretz: Constriction of the pupil usually results in slight headaches. I would be very careful with prescribing presbyopia drops to migraine patients; it would not be my first choice. 

Ben LaHood: I can see VUITY being especially useful for early presbyopes. Pilocarpine, the active ingredient of VUITY, is known to cause anterior segment inflammation when used long term, so I would avoid it in patients with a history of uveitis. I also have concerns about using it in patients where vision quality in low light conditions is important, such as truck drivers. This is because the optical effect of VUITY is based on creating a smaller pupil and this ultimately will reduce the amount of light entering the eye, and reduce vision quality in low light conditions. I also have concerns about giving VUITY to patients with extremely high expectations. If you look at the results of the major studies (1, 2) of VUITY, the actual percentages of patients reaching thresholds of improvement compared to the vehicle drop alone are small. This indicates that it will not work for everyone, so it is best not to get hopes up too much.

Ray Radford: I wouldn’t recommend this option to my patients at all.

Vance Thompson: For patients who are new presbyopes with great distance vision and a normal eye exam this seems like such a natural fit to start their presbyopia journey. Why not try it? Many will love it and some won’t. And the risk is low so why not have them decide after a trial if it is for them? And remember, for some it may not be as great for near as they want and they may use some readers, but I predict many will like it for computer and will also not have to grab their readers as much.

Blake Williamson: The trials looked at patients down to -4 D, so I would be more cautions with high myopes. They would certainly need a good retinal exam. I would recommend starting with patients in their 40s and 50s who don’t have high prescriptions and are just looking to get rid of reading glasses. There are various other potential functions of VUITY that can be examined further – perhaps pseudophakic patients after cataract surgery with a monofocal lens who would like to have better near vision? Many things are possible, but I would still start with the basic indication.

What other similar therapeutics would you like to see in the market? 

Arthur Cummings: Perhaps a drop that has a similar effect, but without pilocarpine, or a weaker dose of pilocarpine. This may be a moot point if time shows that the risk of retinal detachment in previous high myopia is not altered by pilocarpine containing drops.

David Goldman: I would like to see similar therapeutics as competition drives innovation, and with more products on the market, we can expect even better results with time.

Kjell Gunnar Gundersen: I have a high degree of scepticism against this approach in general!

Guy Kezirian: I don’t have to reiterate how huge the presby market is – we all know it is huge. There is room for many presby drops. Some may work better than others for intrinsic reasons of carriers, pharma considerations or side effects. Some may be better tolerated in subgroups of patients (pseudophakes, younger presbyopes, blue eyes, brown eyes, myopes, hyperopes) – we’ll figure that out. The more, the merrier, because every new drop will bring a new marketing budget, and greater public awareness that presbyopia can be treated. VUITY is a huge gift to refractive surgery.

Florian Kretz: I’d like to see a drop that restores accommodation as an alternative to the patient having to cope with a small aperture.

Ben LaHood: Concerns about the inflammatory side effects of chronic pilocarpine use have led to the development of combination products containing pilocarpine alongside non-steroidal anti-inflammatory medications. I would feel more comfortable prescribing this for a patient as I would anticipate that if the medication was effective, most patients would continue to use this drop for as long as they could. I would like to see topical medications which soften the crystalline lens and enhance ciliary muscle action without impact on pupil size as this would truly be a treatment for presbyopia rather than simply an optical side effect. As a cataract surgeon, I feel that we can all see the inevitable development of topical medications, which will cause slowing down of cataract formation and maybe even reversal in our careers. Whether ophthalmologists actually want to see these reach the market is a whole other ethical debate!  

Robert Osher: There are next generation presbyopia eye drops already in development based on other miotics, which look promising and have the potential to address some of the short comings of a pilocarpine-based product. I am particularly looking forward the Aceclidine based eye drop in clinical development that has a unique MOA profile and has been shown to achieve ideal pupil size while avoiding overstimulation of the ciliary muscle, which can create unwanted refractive error and other side effects.

Vance Thompson: This drop is leading the way for an explosion of other presbyopia pharmacologic therapies. The reason is we have had optical devices and surgery, but nothing in between for patients who do not want optical devices, but are not ready for surgery. The drops fit this patient population so very well. But we also know they are a demanding population and will want other attributes such as quick onset of action, maximal duration of action, no or minimal reduction in contrast sensitivity/low light image quality, no adverse effects such as redness or stinging, easy on their ocular surface, and comfortable. That is why the race for the perfect drop has opened up the floodgates for multiple companies with multiple products and world-class formulations and chemistry. This will only grow and the presbyopes and eye care practices of the world will benefit from this unmet need that was missing between optical and surgical corrections now being answered.

Blake Williamson: I’m very excited about the fact that we have several more launches coming down the pipeline, but VUITY is the first such eye drop, and it works really well.

Have you had any feedback on VUITY from your patients? Do they see this as a major milestone? 

David Goldman:I’ve seen a veritable cornucopia of responses. Some patients did not like it at all, while others were blown away by the results and feel it is a life changing technology. I have seen multifocal IOL patients say it helps with haloes in the evening.

Vance Thompson:My practice was in the FDA monitored trial for this drop in the United States so we were able to see in the trial this was a game changer and we are also seeing it in our post-approval patients. It is not for everyone, but it is helping a significant amount of people. Also remember, it is useful for post-refractive and cataract patients who may want additional help at near and intermediate. The drop is so versatile.

Vance Thompson:It has been amazing to see the look on a presbyopes face when they feel like they are turning back the clock. I had one patient say, “This is how I used to see up close!” This concept is very intuitive to patients and with proper patient education and quality pre-prescribing exams it can be a huge plus in their life.

Blake Williamson: Patients who have been prescribed VUITY by me are routinely gaining several lines of vision: from J7 to J2! It’s been amazing for me to watch. They are noticing that they don’t need their glasses as much in the workplace. I treat several golfers who tell me that not only can they fill out their score card on the golf course, but they notice an improvement in their distance vision, too! They are able to follow the golf ball better because of pinhole optics. Sometimes use of the drops also cuts out some of astigmatism and other aberrations. Other patients enjoy going to the restaurant and being able to read the menu without their reading glasses.

Any other thoughts?

Guy Kezirian: The presby drops are like a gateway drug to presbyopic refractive surgery. They will work for a while and then people will want to have the convenience of near vision without the drops. Enter refractive surgery. The more drops that come out the more marketing there will be, bringing more patients to your door. Refractive surgeons should embrace this, support this, and capture the upside.

Ben LaHood: My views on Vuity may seem negative but actually, I just want to be evidence-based, and that means being realistic. As with all new products, it is important to actually look at the study results behind the hype, and be objective. Presbyopic patients can be some of the most demanding patients, with the highest expectations. Undoubtedly, there will be some patients for whom a resulting miotic pupil will give what they want and as a self-described “presbyologist” who treats these patients, I am excited to have something to offer those patients that I currently recommend against surgery. My concerns with the study results are that there was a surprising number of patients who saw benefits from instilling the non-active vehicle drop alone, and that the percentage of patients receiving Vuity who did reach thresholds of improvement was relatively low clinically, even if statistically significant. As for my concern, which was not addressed in studies so far regarding chronic pilocarpine use and inflammation, we shall have to wait and see.

Robert Osher: This is an exciting time for presbyopia, with many potential medical and surgical solutions forthcoming. As a long-time practicing ophthalmologist, seeing the first pharmaceutical option come to market is a very promising addition to our toolkit which up until now has been limited to reading glasses and intraocular lenses, all with some limitations. I am looking forward to trying these drops as well as the next generation drops for my patients and even for myself.

Vance Thompson: I want to emphasize that the practices that respect the impact of presbyopia on a patient’s functionality, aesthetics, physical activity (falls, hip fractures, and head injuries due to bifocals), psychological, even mental health, and finally productivity, are the practices that will benefit the most and help the most patients. Presbyopia is a big problem in our world and the practices that respect it and grow with the options, including presbyopia drops, are the practices that will help the most patients. These drops are the beginning of a wonderful revolution in presbyopia.

Blake Williamson: I think the availability of VUITY will increase the volume of presbyopia-correcting IOLs that we place, and the volume of custom lens replacement in general. I think it will also increase the volume of glasses prescriptions on the optometry side as there will be more visits, and a greater understanding of presbyopia in the general public. There are 128 million of presbyopes in the US alone! If we get them to come into our office, they will want some drops, and potentially some glasses as well. After a year or two of using VUITY, they may decide to go for a permanent option and talk to us about a presbyopia-correcting lens. What’s really important, however, is that once they come through the door encouraged by availability of VUITY, we can diagnose and address their other conditions, such as diabetic retinopathy. Satisfied patients will recommend the practice to their family and friends, so more people will access eye care and practices will gain loyal and committed patients.