Presbyopia-correcting drops bridge the gap between refractive procedures
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As presbyopia-correcting drops have started to enter the marketplace, many anterior segment surgeons are talking about what our role in prescribing these drops will be.
Some have questioned whether we ought to devote time and energy at all to a nonsurgical solution. Personally, I see only upside in finding ways to successfully offer presbyopia-correcting drops to our patients.
Source: Neda Shamie, MD
We can learn some important lessons on this front from our colleagues in plastic surgery who were initially wary of Botox (onabotulinumtoxinA, Allergan) injections and dermal fillers, fearing these nonsurgical procedures would sabotage their surgical business. It is true that some patients postponed facelifts for a few years. But they also became accustomed to not having wrinkles. They continued to seek out cosmetic procedures, up to and including facelifts, as they progressed on their journey to stay youthful. We will find the same thing with patients’ journey to maintain youthful vision.
Presbyopia drops can bridge the gap between refractive procedures offered at a younger age and lenticular-based procedures with premium IOLs later in the life journey of a patient seeking spectacle independence. When patients reach the stage of having significant lenticular changes, the conversation about whether to choose a presbyopia-correcting IOL will be an easy one.
The gap years
Another reason this “bridge” is so important is that it gives us something to offer patients during the 10- to 20-year period when there are not good options.
Consider the typical 45-year-old emmetrope who has never worn glasses before. They do not understand the concept of presbyopia, so they schedule a LASIK consult to see if we can fix their blurry vision. Before drops, I could offer monovision LASIK, but only with hesitation. I know that emerging presbyope is going to continue to lose accommodation over the next decade, and the monovision target I set may stop working for them. A monovision contact lens trial is labor intensive and destined to fail in the approximately 20% of patients who cannot tolerate the anisometropia (I am one of them).
The only other surgical option is refractive lens exchange, which I also hesitate to offer when presbyopia is the only complaint. Refractive lens exchange with a presbyopia-correcting IOL would expose the patient to the risks (albeit low) of intraocular surgery, take away their remaining natural accommodation, and potentially introduce new dysphotopsias or quality-of-vision complaints.
The third option has been to turn the patient away, recommending they get reading glasses until they are “ready” for surgery. At the least, you may lose the patient’s confidence in you, and they may leave frustrated, never to return. Another outcome in this scenario is that the patient will turn to reading glasses and maybe even get accustomed to them, so much so that spectacle independence leaves their list of priorities. This would be a disservice for a patient who would otherwise be able to maintain a youthful and more active outlook. Pupil-modulating presbyopia drops can instead help us keep that patient engaged throughout their journey, transitioning from LASIK or emmetropia to drops and then finally to surgery with premium IOLs.
Factors to consider
Vuity drops (pilocarpine HCl ophthalmic solution 1.25%, Allergan) are available now, and there are several other pupil-modulating products under development in the U.S. We will likely find that some patients respond better to one drop or another, so having multiple options will be beneficial. In evaluating which ones to offer my patients, I will look at efficacy, duration and side effect profile.
The required endpoint for these products is gaining at least three lines of distance-corrected, mesopic, binocular near acuity without losing distance vision. That is a steep goal to meet, and even patients who fall short of three lines may still be satisfied with a smaller gain in near, especially if there is no impact on their distance vision.
We know that most patients do not want to have to instill drops multiple times throughout the day and would likely prefer a “one-and-done” drop they can instill in the morning and benefit from all day. We do not currently have a drop that will last for more than 7 hours for the majority of people, but publicly available study data for Brimochol PF (carbachol and brimonidine tartrate, Visus Therapeutics) suggest that we may in the future (Figure 1).
Side effects such as headache and browache were common with earlier-generation miotics, but presbyopia-correcting drops have lower doses of the active ingredients, as well as advanced formulations that reduce side effects. In the recently published Gemini 1 study, for example, headache was reported by 14% of the patients who used 1.25% pilocarpine once daily for 30 days vs. 9% in the placebo group, and in 87% of cases, it was mild and transient. There were no discontinuations due to headache. Other side effects, including blur, irritation, pain, hyperemia and nausea, were reported at low rates of 2.5% each in the Gemini 1 study.
At the 2022 American Society of Cataract and Refractive Surgery meeting, investigators in the clinical trial of CSF-1 (pilocarpine hydrochloride 0.4%, Orasis) reported good tolerability and safety, with mild and transient adverse events. An early clinical study of Brimochol PF, currently in phase 3, also reported no headache or browache symptoms.
This is an exciting time to start thinking about spectacle independence as a lifelong journey, with different solutions for patients at different stages of that journey. As surgeons, we can collaborate with other eye care specialists in guiding our patients through their journey and helping them maintain youthful vision for as long as possible.
Given recent reports of retinal detachment (RD) following miotic use and subsequent updates to the prescribing information for Vuity, clinicians are advised to perform a dilated retinal exam and evaluate patient history for RD risk factors prior to prescribing pupil-modulating drops for presbyopia. Most of the cases of RD occurred in patients who would have been excluded from clinical trials for these drops due to retinal risk factors.
- References:
- Abdelkader A. Int J Ophthalmic Res. 2019;doi:10.17554/j.issn.2409-5680.2019.05.89.
- Aceclidine: The only pupil selective miotic. https://lenz-tx.com/pipeline/aceclidine/. Accessed Sept. 28, 2022.
- ASCRS. https://ascrs.org/clinical-education/clinical-reports. Accessed Nov. 15, 2022.
- Barnett M, et al. Patient motivations & expectations of presbyopia-correcting drops. Presented at: American Academy of Optometry meeting; Nov. 3-6, 2021; Boston.
- Lindstrom RL, et al. Phase 2b clinical trial to evaluate the safety and efficacy of CSF-1 for the treatment of presbyopia. Presented at: American Society of Retina Specialists annual meeting; July 13-16, 2022; New York.
- Visus Therapeutics announces positive topline clinical data from phase 2 VIVID study of Brimochol for the treatment of presbyopia. https://uploads-ssl.webflow.com/61088b48cbb6c4347abaaca5/61a59e76db9866f53d6a005b_Visus%20Therapeutics%20Brimochol%20Phase%202%20Results_11292021%20FINAL.pdf. Published Nov. 30, 2021.
- Waring GO 4th, et al. JAMA Ophthalmol. 2022;doi:10.1001/jamaophthalmol.2022.0059.
- For more information:
- Neda Shamie, MD, can be reached at Maloney-Shamie Vision Institute, 10921 Wilshire Blvd., Suite 900, Los Angeles, CA 90024; email: ns@maloneyshamie.com.
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