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Point/Counterpoint: Favored Presbyopia Treatment Options

With a new correction modality recently approved, will one method stand out from the rest?

Ever find yourself overwhelmed by the treatment choices available for your presbyopic patients? Now there’s a new one to consider. You want to offer your patients educated, insightful information about their options, but if you don’t have first-hand experience with said options, delivering on that goal can be tough. Perhaps the following three perspectives will help you better navigate your future conversations.

Presbyopia–Correcting Drops: An Option for Everyone

By Cecelia Koetting, OD, FAAO

Game changer alert! In October, the FDA approved pilocarpine HCl ophthalmic solution 1.25% (Vuity, Allergan, an AbbVie company), for the treatment of presbyopia. There are more than five other presbyopia–correcting drops in different stages of FDA trials. These drops use three main pharmaceutical categories (ie, pilocarpine, carbachol, and aceclidine), as a base, all of which use a pinhole effect to increase depth of focus.

THE DROPS UP CLOSE

Vuity, CSF-1 (Orasis Pharmaceuticals), and several other presbyopia–correcting drops contain pilocarpine in different percentages to cause miosis. The second formulation category, exemplified by Brimochol (Visus Therapeutics), uses carbachol, a cholinergic agent, and brimonidine tartrate, an alpha-2 agonist, to decrease pupil size and create a pinhole effect. LNZ100 (Lenz Therapeutics) uses aceclidine, the third formulation category, to target the iris sphincter and avoid ciliary stimulation to obtain the same pinhole effect.

Quickness of Effect

Average onset for these drops are reported anywhere from 15 to 30 minutes, with functional duration of each ranging from 3 to 7 hours. This can be beneficial for patients looking to use a drop for a special occasion and for those looking to use it all day at work.

Study Findings

The studies for each formulation are promising. Vuity’s phase 3 GEMINI 1 and 2 studies showed that 31% and 26% of patients, respectively, gained 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity without losing more than 1 line of BCDVA. The vehicle arm only noted 8% and 11%, respectively, meeting the same endpoints.1

Ocuphire Pharma’s formula, 0.75% phentolamine ophthalmic solution (Nyxol), with low dose pilocarpine, met primary endpoints of 3 lines or more binocular near vision in 63% of patients versus 28% in placebo.2

The phase 2b study of CSF-1 successfully met its primary endpoint of 3 lines of improvement in near vision with no reduction in distance or night vision.3 Previous studies of Brimochol showed an average improvement in near vision of more than 5 lines with no complaints of brow ache or loss in distance vision.4 CSF-1 is currently in phase 2 studies.

LNZ100 exhibited 81% of patients gaining at least 2-line improvement and 53% gaining at least 3-line improvement at 30 minutes in phase 2b trials, with no change to BCDVA.5

Additionally, FDA trials are underway for UNR844 (Novartis Pharmaceuticals), which is comprised of lipoic acid choline ester chloride 1.5% and works to restore the accommodative ability of the crystalline lens. Lipoic acid helps to hydrolyze the disulfide bonds within the crystalline lens proteins to soften the lens. Phase 2 studies found an increase in DCNVA of 6.1 letters in the treatment group versus 4.5 letters in the placebo group.6

Lastly, EyeFocus (OSRX Pharmaceuticals) is a compounded combination of medications including pilocarpine, but there are no ongoing studies. The initial proof of concept study had great promise, with 66% of patients having near vision of 20/40 or better at 1 hour and 78% of patients maintaining this for 8 hours.7

A NO-BRAINER

Presbyopia–correcting drops are an easy button. Patients don’t have to worry about losing their readers, their contact lenses shifting or drying out, or the level of environmental lighting. They simply instill a drop in the morning, go to work, and function! As other drops are approved by the FDA and patients have options, they may need to take another drop in the afternoon.

An even bigger incentive to using presbyopia–correcting drops than those mentioned above is that they create more options for patients in an age where all patients want are options. They may elect to use the drops every day or only in certain situations, but the choice is theirs to make.

MULTIPLE OPPORTUNITIES

Premium IOLs can come with a sticker price that may be difficult for patients to swallow. I believe that many of these patients will choose whichever IOL their insurance will pay for and end up still needing to wear eyeglasses or contact lenses or use a presbyopia–correcting drop. Even those who opt for a premium IOL occasionally need glasses to help in certain situations, such as reading smaller print. These patients will also benefit from the use of presbyopia drops to remain glasses free.

Presbyopic patients who wear contact lenses often find themselves struggling to adapt to multifocal or monovision contact lens wear. On top of that, many also have to contend with worsening dry eye disease. The use of presbyopia–correcting drops would be beneficial in not only alleviating functional vision problems, but also in decreasing the provocation of dry eye disease aggravation.

FUTURE PREDICTIONS

Although the presbyopia–correcting drops coming to market all work on the same pinhole effect principle, they will likely not perform the same, and there will likely be certain circumstances in which one works better than another. I predict that I will offer this option to the majority of my patients, with the caveat that as I understand how each drop works, I will tailor my choice based on each patient’s needs, similar to how I approach the fitting of contact lenses.

Five years from now, I think we will see a good mix of use of all of the presbyopia–correcting options and, overall, a lot more situational use of drops, contact lenses, and glasses, even after premium IOL implantation. Emerging presbyopes and millennials, I believe, will gravitate more towards the use of drops, simply for their immediate effect and ability to combine their use with glasses.

1. Highlights of prescribing information. Allergan, an AbbVie Company. www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf. Accessed January 4, 2022.

2. Nyxol eye drops. Ocuphire Pharma. www.ocuphire.com/product-pipeline/nyxol. Accessed January 14, 2022.

3. CSF-1 overview. Orasis Pharmaceuticals. www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf. Accessed January 4, 2022.

4. Visus Therapeutics announces FDA acceptance of IND for presbyopia-correcting eye drop. Business Wire. March 16, 2021. www.accessdata.fda.gov/drugsatfda_docs/label/2021/214028s000lbl.pdf. Accessed January 4, 2022.

5. Pipeline. Lenz Therapeutics. https://lenz-tx.com/pipeline/aceclidine/. Accessed January 4, 2022.

6. A study of safety and efficacy of UNR844 chloride (UNR844-Cl) eye drops in subjects with presbyopia. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/results/NCT03809611?term=NCT03809611&draw=2&rank=1&view=results. Updated October 11, 2021. Accessed January 4, 2022.

7. Davidson J. Kimbro P. Coming soon: presbyopia-correcting eye drops. Modern Optometry. 2020;2(6):42-44.



The Case for Multifocal Contact Lenses and Progressive Spectacle Lenses

By Joshua Davidson, OD, FSLS, FAAO

The FDA approval of pilocarpine HCl ophthalmic solution 1.25% (Vuity; Allergan, an Abbvie company) in October was truly a watershed moment that will change the way we practice each day. To have the opportunity to reduce our patients’ dependence on OTC readers will change the daily lives of potentially millions of our patients for the better. I see myself prescribing this drop daily and using it to successfully grow my clinic.

Also, as an optometrist working at a high-volume cataract and refractive surgery clinic, I have seen just how incredible the current generation of presbyopia–correcting IOLs are. Each day, I see patients on their postoperative visits near tears because of the incredible satisfaction with their lens exchange surgery. Assuredly as technology improves, skilled surgeons such as Michael Greenwood, MD, and the surgeons I work with at the Williamson Eye Center will continue to hone their skills and achieve even more incredible outcomes. However, being an elective surgery, this option will always be just a little too aggressive for most of our patients.

As incredible and promising as these two developing treatments are for presbyopia, I believe there is nothing quite as successful, nor easy, as multifocal contact lenses or progressive spectacle lenses.1

THE MULTIFOCAL MARKET

In a whirlwind of innovation, we have seen multiple new developments in the multifocal contact lens space. Recently, the Acuvue Oasys Multifocal (Johnson & Johnson Vision), the Bausch + Lomb Ultra Multifocal for Astigmatism (Bausch + Lomb), the Biofinity toric multifocal (CooperVision), and the MyDay multifocal (CooperVision), a Natural View Multifocal redesign, among others, have made their way to market. These lens companies understand that both emerging and established presbyopes are a burgeoning target demographic for the latest lens products. These companies are investing substantial money to develop the best technology in optics to give patients an incredible visual experience with their newest designs.

STICK WITH THE TRIED AND TRUE

The simple beauty of the multifocal (namely soft) contact lens segment is that it can be fit through trial and error in the office multiple times without substantial difficulty. (This is obviously not the case with presbyopic IOL surgery, in which you have one chance to get it right.) Additionally, if the first multifocal lens design isn’t ideal, you can simply have the patient try another with no major loss besides both your time and your patient’s time. Surely just as presbyopia IOL technology continues to improve, so too will multifocal contact lens technology, along with its market share.

It goes without saying just how effective spectacle lenses have been throughout the years. Ever since Benjamin Franklin crafted the first pair of bifocal spectacles in 1784, constant innovation has permeated the field to improve patient satisfaction. It seems that each year, the dominant players in the industry introduce new progressive designs with improved vision at nearly all distances. Interestingly, a study from nearly 15 years ago, well before the advent of many of today’s newest progressive designs, found that 96% of patients surveyed considered progressive lenses either “good or very good.”2

Much like cell phones from the early 2000s are considered archaic, so too are progressive designs from that era. With digital freeform manufacturing becoming more commonplace and manufacturing processes becoming more intricate, the sky is truly the limit regarding progressive lenses. Not to mention there isn’t anything much easier than simply putting glasses on in the morning and taking them off at the end of the day, allowing you to achieve a completely personalized visual experience.

Glasses also allow our patients to express their individuality through frame selection, which of course allows us as optometrists the opportunity to showcase our skills in fitting them with the best possible frame. Should the patient’s prescription or visual status change, which we expect because the progressive loss of near vision is the result of aging, the patient can simply be rerefracted and purchase new glasses with that new prescription, returning them to the best possible vision they can achieve.

What if the patient’s visual demands change, and their standard “all purpose” pair of progressives does not work up to the required standard? No problem, their knowledgeable optometrist can create various glasses designed for specific tasks. As an engineer, do they prefer their three computer screens at exactly 32.75 inches away from their face with their handwritten notes at 18 inches? Great, a custom pair of workspace progressives will give them exactly what they’re looking for. What about that recently retired worker who’s finally able to spend as much time as he desires in the woods hunting, doing his best Fred Bear impression? Let’s make him a pair of shooting glasses with a nice tint on them to increase contrast in the woods.

Absolutely nothing allows patients and practitioners the ability to customize visual outcomes as well as the tried-and-true pair of spectacles. Sure, other modalities will continue to evolve and improve, but so too will progressive glasses, and I’ll happily recommend all of these options each day. This is truly where modern optometrists will hold the advantage.

HITTING ALL THE MARKS

Our job as optometrists is to embrace new methods and technologies in order to improve our patients’ visual experiences. Refractive surgery is an incredible option for patients who are willing to undergo surgery, and presbyopia–correcting drops will work wonders for patients with only near vision issues, but glasses and contact lenses will work for everyone. Although no ideal solution for presbyopia exists, all available options will work together synergistically to offer our patients a custom-tailored approach to meet the needs of their own situation.

1. Toshida H, Takahashi K, Sado K, et al. Bifocal contact lenses: history, types, characteristics, and actual state and problems. Clin Ophthalmol. 2008;2(4):869-877.

2. Krause K. Acceptance of progressive lenses. [Article in German] Klin Monbl Augenheilkd. 1996;209(203):94-99.



IOLs Are the Way to Go

By Michael Greenwood, MD

When it comes to presbyopia, one of the most effective ways to treat it is to go to the source of the problem: the crystalline lens. As we age, this lens becomes less able to zoom in on things up close, and that’s when contact lenses, spectacles, medication, or surgery is needed. The concept of a multifocal IOL was first conceived in 1983 by Kenneth J Hoffer,1 and the technology, like all technology, has only improved with time. There are more options available both in the United States and worldwide, not just in terms of companies that offer IOLs, but also in the technology itself. We have bifocal, trifocal, and extended depth of focus (EDOF) IOLs now available. Each of these types of implants has gradually improved visual outcomes and the visual disturbances between certain IOLs and monofocal IOLs are similar at 6 months.2 In summary, advanced technology IOLs are getting better every year.

GOING TO THE SOURCE

With the increased safety and outcomes that have come with the newer IOL designs, there has been a steady increase in the number of presbyopia–correcting IOLs being implanted by surgeons.3 We have seen this in our own practice as well.

In the past, presbyopic patients who were seeking surgical correction for spectacle independence had fewer options, and would have to rely on laser vision correction with monovision. It was not uncommon for patients in their 50s or 60s to undergo LASIK. Now, with improved IOL technology, these patients can opt for lens-based surgery to treat their presbyopia.

In our practice, patients seeking spectacle independence often come in thinking about LASIK. If they are presbyopic, the discussion includes glasses or contact lenses, laser vision correction, or replacing their natural crystalline lens, the latter of which has several benefits. One of the major benefits is that it can treat both distance and near needs. For example, if a patient has a high myopic or hyperopic prescription or has some astigmatism, one procedure can treat both the myopia/hyperopia/astigmatism, and the presbyopia. Additionally, this patient would no longer need cataract surgery in the future. When patients have lens-based presbyopia correction, both eyes are treated, and the eyes can work synergistically together, allowing better distance and near vision. One of the generally underrated benefits of both eyes being treated is that the brain is able to neuro-adapt better, which decreases dysphotopsia and increases satisfaction.

SIDE EFFECTS VS. REVERSIBILITY

Although patients have many options for correcting their presbyopia, they are not all equal for all patients. Contact lenses continue to improve just as IOLs do, but most patients are looking to be out of contact lenses. They can be burdensome in terms of needing them for daily use, and they can also aggravate ocular surface disease.

Prescription medications can also work well, but they are not without drawbacks. For example, patients need to be nearly emmetropic in order for them to work properly, and as with all medications, there will be side effects, some of which may be minor, but can include ocular surface irritation and brow ache. Patients also need to use presbyopia-correcting drops daily and up to multiple times per day. On the plus side; however, both contact lenses and medications are reversible options, unlike IOL implants.

ALL OPTIONS ASIDE, DO WHAT’S IN THE BEST INTEREST OF THE PATIENT

Most patients who present to our practice have tried nonsurgical options, and therefore, we have a tendency to proceed right away to surgical intervention. However, there are plenty of times that we do not perform surgery, and patients continue with what they are currently doing. This is due to a variety of reasons, but it usually comes down to the fact that surgery is not in the best interest of that particular patient.

It is difficult to predict which therapy will be most requested in the future. One thing is certain: With more tools in our toolbox, we will be able to fit the technology to the patient and provide them with an option that fits their needs.

1. Hoffer KJ, Savini G. Multifocal intraocular lenses: historical perspective. Essentials in Ophthalmology. 2014;5-28.

2. Alcon PanOptix Directions For Use product information.

3. MarketScope Q3-2021 Cataract Surgeons Report.

author
Joshua Davidson, OD, FSLS, FAAO
  • Optometrist, Williamson Eye Center, Baton Rouge, Louisiana
  • Member, Modern Optometry Editorial Advisory Board
  • jdavidson@weceye.com; Instagram @dryeyeod
  • Financial disclosure: Speaker (Allergan)
author
Michael Greenwood, MD
author
Cecelia Koetting, OD, FAAO

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