Drug Update · Ophthalmology

FDA Approves Yuvezzi for Presbyopia: 38.2% Achieve 3-Line Near Gain in BRIO II

July 11, 2026

FDA approval date

2026-01-28

Approved dose

One drop in each eye once daily (carbachol 2.75% / brimonidine tartrate 0.1%)

BRIO II primary result

38.2% Yuvezzi vs 3.7% vehicle achieved 3-line BUCNVA gain at Hour 1

Clinical Perspective

This approval affects clinicians who treat adults with presbyopia, including ophthalmologists and other eye-care clinicians, by providing a topical pharmacologic option for improving near vision in adults ^[4]^[5]. The BRIO data support that a single daily instillation of Yuvezzi can produce a clinically meaningful binocular near-vision gain (3-line/15-letter) in a subset of patients, with randomized vehicle-controlled evidence at Hour 1 showing 38.2% versus 3.7% ^[5]. An important unanswered clinical question is how to optimize patient selection and counseling about duration of effect, night-vision trade-offs, and retinal-screening strategies in routine practice?

Dr. Ravi Krishnan · Ophthalmology

The FDA approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) for the treatment of presbyopia in adults on 2026-01-28 based on randomized BRIO studies showing improved near visual acuity after a single drop once daily ^[3]^[5]. Clinicians should consult current prescribing information for full dosing guidance. In BRIO II, 38.2% of Yuvezzi-treated participants achieved a gain of 3 lines (15 letters) or more in binocular uncorrected near visual acuity without losing 1 line or more in distance acuity at Hour 1 versus 3.7% with vehicle ^[5]^[3].

Clinical Context

Yuvezzi is a fixed-dose topical ophthalmic combination of carbachol, a cholinergic miotic, and brimonidine tartrate, an alpha-adrenergic receptor agonist, formulated as a preservative-free single-dose vial containing carbachol 2.75% and brimonidine tartrate 0.1% ^[4]^[2]. The combination aims to constrict the pupil and create a pinhole effect to improve depth of focus and near vision; preclinical and early clinical work on parasympathomimetic plus alpha-agonist miotics showed near-vision benefit with miosis in presbyopic subjects ^[1]^[5]. The product is manufactured and labeled via FDA-reviewed submissions and DailyMed prescribing information supplied by the sponsor and approved by FDA ^[3]^[4].

Key Findings

In BRIO II, Yuvezzi achieved a 38.2% proportion of participants who gained 3 lines (15 letters) or more in binocular uncorrected near visual acuity (BUCNVA) without a loss of 1 line (5 letters) or more in binocular uncorrected distance visual acuity (BUCDVA) at Hour 1 versus 3.7% with vehicle in adults with presbyopia (BRIO II) ^[5].
In BRIO I, a single-dose crossover study, Yuvezzi showed superiority on near-vision endpoints versus brimonidine and versus carbachol monotherapies at multiple early timepoints; for example, at Hour 1 Yuvezzi 49.4% versus brimonidine 22.7% and versus carbachol 35.0% (BRIO I) ^[5].
The pivotal program included 536 participants across two Phase 3 studies and measured the primary endpoint as a 3-line (15-letter) binocular near visual acuity gain without a clinically meaningful loss in distance acuity under mesopic conditions; BRIO II provided the randomized vehicle-controlled data supporting the approval ^[5].

Safety & Tolerability

Eye pain upon instillation ^[4].
Visual impairment ^[4].
Eye irritation upon instillation ^[4].
Headache ^[4].
Blurred vision / accommodative spasm warning ^[2]^[4].
Retinal tear and detachment reported with miotics; retinal examination advised prior to initiating therapy ^[2]^[4].
Iritis may be exacerbated with miotic use; Yuvezzi is not recommended when iritis is present ^[2]^[4].
Potentiation of vascular insufficiency (use with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans) ^[4].

Study Design

The FDA approval was supported by two Phase 3 randomized, double-masked controlled studies in adults with presbyopia: BRIO I was a single-dose crossover study (182 participants) comparing Yuvezzi with carbachol and brimonidine monotherapies; BRIO II randomized 436 participants (218 to Yuvezzi, 218 to vehicle) for single-dose efficacy testing and included a long-term safety portion with up to 12 months of exposure, including a 6-month open-label extension ^[5]. The primary endpoint in both pivotal studies was the proportion achieving a gain of 3 lines (15 letters) or more in binocular uncorrected near visual acuity without a loss of 1 line (5 letters) or more in binocular uncorrected distance visual acuity under mesopic conditions ^[5]. FDA original approval date: 2026-01-28 ^[5]^[3].

FAQ

Q1 What is Yuvezzi (brand) approved for?

Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) is approved for the treatment of presbyopia in adults. The indication in the FDA-approved prescribing information specifies topical ophthalmic use to improve near visual acuity in adults with presbyopia. The approval was supported by the BRIO Phase 3 program with randomized evidence of near-vision benefit following once-daily instillation.

Q2 How does Yuvezzi work?

Yuvezzi combines carbachol, a cholinergic agonist that constricts the iris sphincter and acts on the ciliary body, with brimonidine, an alpha-adrenergic agonist that reduces dilator muscle activity and modulates ciliary tone. The proposed mechanism is pupillary constriction that creates a pinhole effect, increasing depth of focus and improving binocular near visual acuity in presbyopic adults.

Q3 What is the recommended dose of Yuvezzi?

The recommended dosing is one drop of Yuvezzi in each eye once daily. The ophthalmic solution formulation is carbachol 2.75% and brimonidine tartrate 0.1% supplied in single-dose vials. Remove contact lenses prior to instillation and wait 10 minutes before reinserting lenses. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects?

In the BRIO studies and prescribing information, the most commonly reported adverse reactions included eye irritation upon instillation, eye pain upon instillation, visual impairment, and headache. Warnings and precautions in the label also note blurred vision, the potential for retinal tear or detachment associated with miotics, exacerbation of iritis, and potentiation of vascular insufficiency in susceptible patients. Clinicians should review the full prescribing information for details on safety monitoring and contraindications.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Yuvezzi for Presbyopia: 38.2% Achieve 3-Line Near Gain in BRIO II

Direct Clinical Takeaway & Evidence Summary

FDA Approves Yuvezzi for Presbyopia: 38.2% Achieve 3-Line Near Gain in BRIO II

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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