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Spotlight on YUVEZZI™

Optometry 360

This Spotlight Series article is editorially independent content.

Presbyopia is an age-related condition characterized by a gradual and irreversible loss of the eye’s ability to accommodate as the lens becomes less elastic. This decline makes it increasingly difficult to focus on near objects and can negatively affect daily functioning and quality of life. Approximately 1.8 billion people worldwide are affected by presbyopia, and this number is projected to reach 2.1 billion by 2030. Available management approaches include eyeglasses, contact lenses, pharmacologic treatments, and surgical procedures, although each has potential drawbacks related to convenience, adaptation, or visual function.1

YUVEZZI™: Dual-Agent Eye Drop for Presbyopia

YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution; Tenpoint Therapeutics) 2.75%/0.1% is the newest addition to the nonsurgical management of presbyopia in adults. Approved by the US Food and Drug Administration (FDA) in January 2026, it is the first and only dual-agent eye drop approved for this condition.2

The proposed mechanism of action of the fixed-dose combination of carbachol and brimonidine for presbyopia involves constriction of the pupil, producing a pinhole effect that improves near visual acuity and depth of focus. Carbachol, a cholinergic agent, causes the iris sphincter and ciliary body to constrict. Brimonidine tartrate, an alpha-adrenergic agonist, inhibits contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle. These effects enhance selectivity for the pupil and increase the bioavailability of carbachol in the aqueous humor.3

Efficacy Data

The efficacy of YUVEZZI was evaluated in 618 adult patients aged 45 to 80 years with presbyopia across 2 randomized, double-masked, controlled phase 3 studies, BRIO I and BRIO II. Both studies enrolled patients with a history of refractive surgery and/or pseudophakia.3

BRIO I was a single-dose crossover study of 182 patients who received YUVEZZI, carbachol alone, and brimonidine tartrate alone, with a washout period of at least 3 days between treatments. In BRIO II, 436 patients were randomly assigned to receive 1 drop of YUVEZZI or vehicle in each eye (n=218 per group). The study continued for 12 months, including a 6-month open-label extension phase.1,3

YUVEZZI produced significant, sustained pupil constriction from 0.5 to 10 hours after dosing compared with either carbachol or brimonidine monotherapy and from 0.5 to 8 hours compared with vehicle (see FIGURE 1).3

In both studies, the primary endpoint was the proportion of patients who gained ≥3 lines (15 letters) in binocular uncorrected near visual acuity without losing ≥1 line (5 letters) in binocular uncorrected distance visual acuity under mesopic conditions. A significantly greater proportion of patients treated with YUVEZZI met this endpoint compared with those receiving vehicle or either individual component.3

Additionally, in BRIO I, YUVEZZI demonstrated superior benefit than either active ingredient, meeting the FDA requirement for fixed-dose combinations.2

In BRIO II, YUVEZZI provided statistically significant improvements in near vision compared with vehicle across all time points through 8 hours. At hour 2, nearly 70% of patients receiving YUVEZZI achieved near visual acuity of 20/40 or better (see FIGURE 2). At 3 months, improvement in reading speed was 6 times greater with YUVEZZI than with vehicle (see FIGURE 3).4

Safety and Tolerability

BRIO II demonstrated that the drop was well tolerated and included more than 72,000 treatment days. The most common adverse reactions (incidence ≥5%) were headache (15.6%), eye irritation upon instillation (14.0%), eye pain upon instillation (6.7%), and visual impairment (6.4%). Most adverse events were mild, transient, and self-resolving. Reports of ocular hyperemia (eye redness) were low in both phase 3 studies. In BRIO II, the proportion of patients experiencing eye redness was 2.8% with YUVEZZI compared with 10.7% with carbachol alone.2-4

Dosing and Administration

YUVEZZI is available in single-dose preservative-free vials that require no same-day redosing or refrigeration. One single-dose vial can be used to dose both eyes. The recommended dosage is 1 drop in each eye daily. YUVEZZI may be used concomitantly with other topical ophthalmic medications. If more than 1 ophthalmic drug is used, administer them at least 5 minutes apart. Contact lenses should be removed prior to instilling YUVEZZI and may be reinserted 10 minutes after administration. Opened vials should be discarded after use.3

For more information, www.yuvezziecp.com.

References

  1. Abid MA, Abid MH, Afzal MD. Yuvezzi™ (carbachol and brimonidine tartrate) dual-agent eyedrops: a new option for presbyopia. Ann Med Surg (Lond). 202614;88(5):3020-3021. doi:10.1097/MS9.0000000000004984
  2. Tenpoint Therapeutics Ltd. announces FDA approval of YUVEZZI™, the first and only combination eye drop approved to treat presbyopia. News release. Tenpoint Therapeutics Ltd. January 28, 2026. Accessed October 1, 2026. https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf
  3. YUVEZZI. Package insert. Visus Therapeutics. 2026.
  4. Visus Therapeutics, Inc. Data on file. VT-003 Clinical Study Report. 2025.

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