The Future of Yuvezzi Eye Drops in Presbyopia, With John Hovanesian, MD

On January 28, 2026, the US Food and Drug Administration (FDA) announced its approval of Tenpoint Therapeutics’ Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults.1

The approval, which was spearheaded by positive data from the BRIO-I and BRIO-II phase 3 trials, marked Yuvezzi as the first and only combination eye drop approved for this indication. In addition to BRIO-I and BRIO-II, Yuvezzi underwent the largest and longest safety study for presbyopia eye drops, achieving miosis from 30 minutes to 10 hours with 1 drop daily.1

“The 2 phase 3 studies, BRIO-I and BRIO-II, looked at Yuvezzi’s efficacy, and found that in this vehicle-controlled study, statistically significant benefits were shown in terms of allowing patients to see better near vision without loss of distance visual acuity, which is the yardstick that the FDA likes to use,” John Hovanesian, MD, principal and owner of Harvard Eye Associates, told HCPLive in an exclusive interview.

BRIO-I and II were both multicenter, double-masked, randomized safety and efficacy studies. Both trials examined patients with emmetropic phakic and pseudophakic presbyopia. BRIO-I compared Yuvezzi to its component parts – carbachol PF and brimonidine tartrate – administered individually, while BRIO-II included carbachol PF and standard vehicle as comparators.2,3

BRIO-I had the primary endpoint of the proportion of subjects with a ≥15 letter gain in binocular near visual acuity (BUCNVA) without a ≥5 letter loss in near visual acuity. BRIO-II, however, measured the change from baseline in near visual acuity, examining the percentage of subjects with 3-line improvement without loss of ≥1 line in distance visual acuity.2,3

Investigators in BRIO-I enrolled male or female patients 45-80 years old with presbyopia. Patients were excluded if they had a history of allergic reaction to the study drug or its components, or if they had a disease or medical condition that might confound study results or prevent participation.2

A total of 182 participants were ultimately enrolled and randomly assigned to receive 1 eye drop of either Yuvezzi, carbachol PF, or brimonidine tartrate at each visit. During the trial, Yuvezzi indicated its durability and tolerability by achieving ≥15 ETDRS letter gain in BUCNVA without a loss of ≥5 letters at distance at all time points through hour 6 (carbachol P = .006; brimonidine P = .039). Additionally, it achieved statistical significance in the proportion of patients achieving a 10-letter gain at near distance and the proportion of patients achieving ≥20/40 at near visual acuity.4

BRIO-II enrolled 629 patients across 42 locations in the US, who were randomly assigned to 1 drop of Yuvezzi, carbachol PF, or vehicle per visit. Ultimately, investigators noted that Yuvezzi demonstrated statistically significant improvements in near vision compared to vehicle at all timepoints out to 8 hours (P <.008). Additionally, it significantly reduced pupil size at all timepoints, which is the central mechanism of action for miotic therapies.5

In both trials, Yuvezzi was well-tolerated with no treatment-related serious adverse events. Eye redness was also uncommon, and in BRIO-II, the rate of reported adverse events of ocular hyperemia was lower in patients assigned to Yuvezzi than those receiving carbochol alone.1

“When we as clinicians think about Yuvezzi, we really have to think from the patients’ perspective, because this is a drug that’s new to us and we have a bit of unfamiliarity with prescribing it, recommending it, educating patients,” Hovanesian said. “And yet, patients are highly motivated. What patients want is to be young again. And of course, we can’t give them that, but we can give them a treatment that will allow them to function as though they were a little bit younger.”

Editor’s Note: Hovanesian reports disclosures with AcuFocus, Inc, Azura Ophthalmics, Ocular Therapeutix, Research InSight, Versant Ventures, Novalic, and others.

References

1. Tenpoint Therapeutics. Tenpoint Therapeutics Ltd. Announces FDA Approval of YUVEZZI, the First and Only Combination Eye Drop Approved to Treat Presbyopia. BusinessWire. January 28, 2026. Accessed February 6, 2026. https://www.businesswire.com/news/home/20260128284402/en/Tenpoint-Therapeutics-Ltd.-Announces-FDA-Approval-of-YUVEZZI-the-First-and-Only-Combination-Eye-Drop-Approved-to-Treat-Presbyopia

2. Visus Therapeutics. Safety and Efficacy Study BRIMOCHOL PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia. ClinicalTrials.gov Identifier: NCT05270863. Updated October 15, 2024. Accessed February 6, 2026. https://clinicaltrials.gov/study/NCT05270863

3. Visus Therapeutics. Safety and Efficacy Study of BRIMOCHOL PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia. ClinicalTrials.gov Identifier: NCT05135286. Updated August 6, 2025. Accessed February 6, 2026. https://clinicaltrials.gov/study/NCT05135286

4. Visus Therapeutics. Visus Therapeutics Presents Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL PF for the Treatment of Presbyopia at Eyecelerator @ ASCRS 2023. BusinessWire. May 4, 2023. Accessed February 6, 2026. https://www.businesswire.com/news/home/20230504005453/en/Visus-Therapeutics-Presents-Topline-Clinical-Data-from-Phase-3-Pivotal-BRIO-I-Trial-of-BRIMOCHOL-PF-for-the-Treatment-of-Presbyopia-at-Eyecelerator-ASCRS-2023

5. Tenpoint Therapeutics. Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II of BRIMOCHOL PF for the Treatment of Presbyopia. January 8, 2025. Accessed February 6, 2026. https://cdn.prod.website-files.com/64b01a75c3f993c7c15191dd/677ff7ffefa72f00cca150c7_PR%20Tenpoint%20Announces%20Positive%20Topline%20Clinical%20Data_8Jan2025_1pm.pdf