Presbyopia correcting drops an opportunity for optometry
The introduction of presbyopia correcting drops can open the door to a large, undertreated group of presbyopic patients.
How do we currently approach presbyopia correction? Most of our options involve some trade-offs. Due to these shortcomings, many patients get to the point of truly struggling with their near vision before they “give in” and seek a solution — one they know probably will not be great. We may not be proactively treating early presbyopes and emmetropes because we know they will not embrace what we have to offer.
Screen time has dramatically changed the demands on near vision, and these demands have increased with the onset of the pandemic. Now 38- to 42-year-olds with early presbyopia are becoming more symptomatic sooner as screen and indoor time has gone up.
In the U.S. there are 128 million people with presbyopia (Zebardast et al.). U.S. adults spend an average of 3 hours and 48 minutes per day on computers, tablets and smartphones (Nielsen) and they check their phones 96 times a day — once every 10 minutes, according to research from Asurion. This combination of prevalence and digital device use will continue to drive research and technology, and therapies will continue to evolve.
With novel presbyopia-correcting pharmaceuticals poised to enter the market, we have a huge opportunity to identify patients who may benefit.
How to prepare
Start laying the ground work now. Social media is the best way to target this demographic, and word of mouth is also powerful. Continually speak with patients about evolving technology and products that may be coming. Let them know that your practice aims to be on the forefront of these advances. “Pre-education” will lead patients to think of your practice when they begin to see social media and direct-to-consumer advertising.
Education around this new modality will build awareness among the public of the need for routine eye exams. Presbyopia-correcting drops will drive more patients to our offices, and we will be identifying glaucoma, age-related macular degeneration, dry eye, hypertension, diabetes and other conditions earlier. There are significant public health benefits associated with this advancement.
Until then, we need to embrace the current methods, tailoring options to each patient. Let them know they have a condition that impacts several different things and that it may take a combination of different tools to fix it. Informing patients that there is no one solution for all situations is part of creating a solid foundation from which to manage presbyopia.
To prepare internally, educate your staff as well. We have started discussing presbyopia-correcting drops at our monthly office meetings. I also advise embracing your sales reps when it comes to new products and leverage them as another way to inform your staff. When the staff is onboard with a change, it will be exponentially more successful.
Clinical trials at a glance
Allergan. Gemini 1 and Gemini 2 phase 3 trials included 750 patients, randomly assigned in a one-to-one ratio of vehicle to AGN-190584 (parasympathomimetic agent pilocarpine 1.25%) (NCT02780115). It demonstrated statistically significant gains of three lines of near vision in low light conditions without loss of distance vision. There were no treatment-emergent serious adverse events observed in any AGN-190584 treated participants.
Novartis. UNR844-CL is a lipoic acid choline ester that acts to break disulfide bonds. Two registered clinical trials have been reported for this twice-a-day drop (NCT03809611). After 3 months, 82% of 125 individuals in the trial had 20/40 visual acuity or better, and 36% had 20/25 visual acuity or better.
Orasis Pharmaceuticals. CSF-1 is a parasympathomimetic that has completed phase 2 clinical trials (NCT04599933). In the multicenter, double-masked investigation of 166 participants, the agent showed a statistically significant improvement in near visual acuity of three or more lines with a good safety and tolerability profile. NEAR-1 and NEAR-2 phase 3 studies are enrolling approximately 600 participants with presbyopia to further evaluate the efficacy and safety.
OSRX Pharmaceuticals. These drops are a compounded combination with phenylephrine (EyeFocus 0.302% and EyeFocus+ 0.604%), pheniramine and ketorolac. According to the company website, nine patients in a proof-of-concept study experienced improved near visual functionality.
Presbyopia Therapies. PRX-100 contains the parasympathomimetic aceclidine. The muscarinic acetylcholine receptor agonist causes pupil constriction in the sphincter muscle of the iris. Phase 2b clinical trials enrolled 58 participants and found that 47.2% gained 3 lines of near visual acuity, and more than 90% gained at least two lines of near visual acuity (NCT02554396). Half the patients maintained the two-line improvement up to 7 hours after drop instillation, and the treatment was well tolerated.
Visus Therapeutics. Brimochol is a proprietary formulation of carbachol — a parasympathomimetic — and brimonidine — an alpha 2 adrenergic agonist. Five clinical studies have been conducted evaluating the safety and efficacy, according to a company press release. In the most recent study of 57 participants, there was a statistically significant improvement in near visual acuity of a five Jaeger-line or greater gain, with the effect lasting at least 12 hours. The drug was well tolerated with no reports of headache or brow ache. Phase 2 trials are slated to commence early this year.
As a profession, we have to identify the appropriate patients and set the right expectations. No one solution is the answer for everyone, and this drop will be another tool we have available to offer our patients a better experience and an easier transition into presbyopia and middle age. The challenge is learning how it fits in your tool kit.
- A safety, efficacy and pharmacokinetic study of AGN-199201 and AGN-190584 in patients with presbyopia. Available at https://clinicaltrials.gov/ct2/show/NCT02780115. Accessed February 9, 2021.
- A study of safety and efficacy of UNR844 Chloride (UNR844-Cl) eye drops in subjects with presbyopia. Available at https://clinicaltrials.gov/ct2/show/NCT03809611. Accessed February 9, 2021.
- Allergan, an AbbVie company, announces positive phase 3 topline results for investigational AGN-190584 for the treatment of presbyopia. Available at https://news.abbvie.com/news/press-releases/allergan-an-abbvie-company-announces-positive-phase-3-topline-results-for-investigational-agn-190584-for-treatment-presbyopia.htm. Accessed February 9, 2021.
- Americans check their phones 96 times a day [press release]. Nashville, TN: PRNewswire; November 21, 2019. Available at https://www.asurion.com/about/press-releases/americans-check-their-phones-96-times-a-day. Accessed January 2, 2021.
- An evaluation of the efficacy and safety of CSF-1 in the temporary correction of presbyopia (NEAR-1) (NEAR-1). Available at https://clinicaltrials.gov/ct2/show/NCT04599933. Accessed February 9, 2021.
- Care of the patient with presbyopia. American Optometric Association website. Available at https://www.aoa.org/documents/optometrists/CPG-17.pdf. Accessed March 29, 2019.
- Evaluation of the efficacy and safety of PRX-100 in the treatment of early to moderate presbyopia. Available at https://clinicaltrials.gov/ct2/show/NCT02554396. Accessed February 9, 2021.
- People spend most of their waking hours staring at screens. MarketWatch website. Available at https://www.marketwatch.com/story/people-are-spending-most-of-their-waking-hours-staring-at-screens-2018-08-01. Published August 4, 2018. Accessed January 2, 2021.
- Presbyopia therapies announces primary safety and efficacy endpoints met in a phase 2b study of its topical PRX ophthalmic solution for the treatment of presbyopia. Available at https://www.prnewswire.com/news-releases/presbyopia-therapies-announces-primary-safety-and-efficacy-endpoints-met-in-a-phase-iib-study-of-its-topical-prx-ophthalmic-solution-for-the-treatment-of-presbyopia-300688070.html. Accessed February 9, 2021.
- The Nielsen Total Audience Report Q1 2018. Nielsen Company website. Available at https://www.nielsen.com/us/en/insights/report/2018/q1-2018-total-audience-report. Accessed January 2, 2021.
- U.S. Census Bureau. Table 9. Projections of the population by sex and age for the United States: 2015 to 2060 (NP2014-T9). Washington: Population Division. 2014.
- Vision Council website. Available at https://www.thevisioncouncil.org/sites/default/files/research/VisionWatch_VisionCouncil_Member_Benefit_Report_September%202016_FINAL.pdf. Accessed January 2, 2021.
- Visus Therapeutics launches and announces clinical development program for novel presbyopia eye drop. Available at https://tinyurl.com/y2k6huyo. Accessed February 9, 2021.
- Zebardast N, et al. Am J Ophthalmol. 2017;doi:10.1016/j.ajo.2016.11.004.
For more information:
Shane R. Kannarr, OD, is in private practice at Kannarr Eye Care, Pittsburg, Kansas. He may be reached at firstname.lastname@example.org.