YUVEZZI- carbachol and brimonidine tartrate solution/ drops

YUVEZZI by

Drug Labeling and Warnings

YUVEZZI by is a Prescription medication manufactured, distributed, or labeled by Visus Therapeutics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    YUVEZZI™ is indicated for the treatment of presbyopia in adults.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Recommended Dosage

    The recommended dosage of YUVEZZI is one drop in each eye once daily.

    2.2 Administration Instructions

    Remove contact lenses prior to instillation of YUVEZZI. Wait 10 minutes after dosing before reinserting contact lenses.

    If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

    One single-dose vial can be used to dose both eyes. Discard the open single-dose vial and any remaining contents immediately after use.

  • 3 DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution: carbachol 2.75% (27.5 mg/mL) and brimonidine tartrate 0.1% (1 mg/mL) as a clear, greenish-yellow ophthalmic solution in single-dose vials.

  • 4 CONTRAINDICATIONS

    YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Blurred Vision

    Miotics may cause accommodative spasm. Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision).

    In addition, patients may experience temporary dim or dark vision with miotics. Advise patients to exercise caution in night driving and other hazardous activities in poor illumination.

    5.2 Risk of Retinal Detachment

    Rare cases of retinal tear and detachment have been reported with miotics. Individuals with pre-existing retinal disease are at increased risk. Examination of the retina is advised in all patients prior to the initiation of therapy.

    Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.

    5.3 Iritis

    Sequelae of ocular inflammation, i.e., adhesions (synechiae) between the iris and the lens, may be exacerbated with miotic use, therefore, YUVEZZI is not recommended to be used when iritis is present.

    5.4 Potentiation of Vascular Insufficiency

    YUVEZZI may potentiate syndromes associated with vascular insufficiency. YUVEZZI should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

    5.5 Potential for Eye Injury or Contamination

    To prevent eye injury or contamination, avoid touching the single-dose vial to the eye, eyelids, or to any other surface.

  • 6 ADVERSE REACTIONS

    The following clinically significant adverse reactions are described elsewhere in labeling:

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    YUVEZZI was evaluated in 536 patients with presbyopia in two randomized, double-masked, controlled studies. BRIO™ I (NCT05270863) was a single-dose crossover study in which 178 patients received YUVEZZI. BRIO II (NCT05135286) included 358 patients who received YUVEZZI in the long-term safety portion of the study (up to 12 months duration, including a 6-month open-label extension). Adverse reactions reported in > 5% to 7% of participants were eye pain upon instillation and visual impairment. Adverse reactions reported in > 10% to 16% of participants were eye irritation upon instillation and headache. The majority of adverse events were mild, transient, and self-resolving.

  • 7 DRUG INTERACTIONS

    7.1 Antihypertensives/Cardiac Glycosides

    Because brimonidine tartrate, a component of YUVEZZI, may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with YUVEZZI is advised.

    7.2 CNS Depressants

    Although specific drug interaction studies have not been conducted with YUVEZZI, the possibility of an additive or potentiating effect with central nervous system (CNS) depressants (alcohol, opiates, barbiturates, sedatives, or anesthetics) should be considered.

    7.3 Tricyclic Antidepressants

    Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with YUVEZZI in humans can lead to resulting interference with pupil constriction effects. Caution is advised in patients taking tricyclic antidepressants, which can affect the metabolism and uptake of circulating amines.

    7.4 Monoamine Oxidase Inhibitors

    Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine tartrate and potentially result in an increased systemic side effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no adequate and well-controlled studies of YUVEZZI administration in pregnant women to inform a drug-associated risk. Topical ocular administration of YUVEZZI to pregnant rats throughout organogenesis did not produce adverse effects up to 3 times the maximum recommended human ocular dose (MRHOD). Topical ocular administration of YUVEZZI to pregnant rabbits throughout organogenesis at approximately 3 times the MRHOD resulted in maternal toxicity with no effect on the fetus, including reduced maternal food consumption, body weight change, and related moribundity in 2/25 animals during the dosing period. Body weight and food consumption effects recovered after the dosing stopped ( see Data).

    Because animal reproductive studies are not always predictive of human response, YUVEZZI should be administered during pregnancy only if the potential benefit justifies the potential risk to the pregnant mother and fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

    Data

    Human Data

    No adequate and well-controlled trials of YUVEZZI have been conducted in pregnant women.

    Animal Data

    YUVEZZI was not teratogenic in embryofetal development studies when given by topical ocular administration to pregnant rats or rabbits throughout organogenesis at dose levels up to approximately 3 times the MRHOD of 1.815 mg/day carbachol and 0.066 mg/day brimonidine tartrate based on body surface area scaling. Topical ocular administration of YUVEZZI to pregnant rats on gestation days (GD) 6 to 17 at dose levels of up to 0.224 mg/day carbachol and 0.008 mg/day brimonidine tartrate (approximately 3 times the MRHOD, based on body surface area) produced no maternal toxicity or embryofetal effects. Topical ocular administration of YUVEZZI to pregnant rabbits on GD 7 to 19 at the dose level of 1.12 mg/day carbachol and 0.04 mg/day brimonidine tartrate (approximately 3 times the MRHOD, based on body surface area scaling) led to maternal toxicity with no embryofetal effects. Maternal findings included significantly reduced food consumption (41%) and body weight change (-87%), with related moribundity in 2/25 animals during the dosing period, compared with the vehicle control group. Body weight and food consumption effects resolved after a 10-day recovery period.

    8.2 Lactation

    Risk Summary

    There is no information regarding the presence of carbachol and brimonidine tartrate in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of YUVEZZI to an infant during lactation.

    Systemic levels of carbachol and brimonidine tartrate following topical ocular administration of YUVEZZI are low [see Clinical Pharmacology (12.3)] , and it is not known whether measurable levels of carbachol and brimonidine tartrate would be present in maternal milk following topical ocular administration.

    The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YUVEZZI and any potential adverse effects on the breastfed child from YUVEZZI.

    8.4 Pediatric Use

    Presbyopia does not occur in the pediatric population.

    8.5 Geriatric Use

    No overall differences in safety or effectiveness have been observed between elderly and adult patients.

  • 10 OVERDOSAGE

    Systemic toxicity following topical ocular administration of carbachol is rare, but patients who are sensitive may occasionally develop sweating and gastrointestinal overactivity. Accidental ingestion can produce sweating, salivation, nausea, and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For patients demonstrating severe poisoning, use atropine, the pharmacologic antagonist to carbachol.

    Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

  • 11 DESCRIPTION

    YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75% / 0.1% is a fixed-dose combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, for topical ophthalmic use. YUVEZZI is formulated as an isotonic, sterile, clear, greenish-yellow ophthalmic solution. YUVEZZI does not contain an anti-microbial preservative.

    The chemical name for carbachol is 2-carbamoyloxyethyl(trimethyl)azanium chloride. The molecular weight is 182.648 g/mol and the molecular formula is C 6H 15ClN 2O 2. Its structural formula is:

    Chemical Structure

    The chemical name for brimonidine tartrate is 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine L-tartrate. The molecular weight is 442.226 g/mol and the molecular formula is C 15H 16BrN 5O 6. Its structural formula is:

    Chemical Structure

    Each mL of YUVEZZI contains carbachol 2.75% (27.5 mg/mL) and brimonidine tartrate 0.1% (1 mg/mL) as the active ingredients. Inactive ingredients are: hydroxypropyl methylcellulose (HPMC), sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, water for injection, and may also include hydrochloric acid and/or sodium hydroxide to adjust pH, if necessary.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    The proposed mechanism of action of this fixed-dose combination of carbachol and brimonidine in presbyopia is pupillary constriction and the creation of a pinhole effect that improves near visual acuity and depth of focus. Carbachol is a cholinergic agent which produces constriction of the iris sphincter and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, blocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, enhancing selectivity for the pupil and increasing bioavailability of carbachol in the aqueous humor.

    12.2 Pharmacodynamics

    Pupil size was assessed using automated digital pupillometry under mesopic conditions. Average pupil diameter reduction following YUVEZZI was significantly superior to both active monotherapies from pre-dose baseline to Hour 0.5 through Hour 10 in the BRIO I study, and to vehicle from pre-dose baseline to Hour 0.5 through Hour 8 in the BRIO II study.

    12.3 Pharmacokinetics

    Absorption

    Systemic exposures to brimonidine tartrate and carbachol were evaluated in participants with presbyopia who were administered 1 drop of YUVEZZI to each eye. Brimonidine tartrate plasma concentrations were quantifiable in 5 of 14 subjects, with C maxand T maxup to 0.066 ng/mL and 0.52 hours respectively. Carbachol plasma concentrations were quantifiable in 6 of 14 subjects, with C maxand T maxup to 1.02 ng/mL and 4.42 hours respectively.

    Distribution

    Brimonidine is approximately 29% bound to plasma proteins in healthy subjects. The protein binding of carbachol has not been studied.

    Elimination

    Metabolism

    In humans, brimonidine is extensively metabolized by the liver. Metabolism of carbachol has not been studied.

    Excretion

    Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine. Excretion of carbachol has not been studied.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis

    Long term studies in animals have not been performed to evaluate carcinogenic potential of YUVEZZI or carbachol.

    No brimonidine tartrate–related carcinogenic effects were observed with dietary administration at dose levels up to 2.5 mg/kg/day in mice for 21 months or 1 mg/kg/day in rats for 24 months.

    Mutagenesis

    Carbachol was not mutagenic or clastogenic in a battery of in vitro and in vivo studies including the Ames bacterial reverse mutation test, an in vitro micronucleus assay in TK6 cells, and an in vivo rat bone marrow micronucleus assay.

    Brimonidine tartrate was not mutagenic or clastogenic in a series of in vitro and in vivo studies, including the Ames bacterial reverse mutation test, a chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and 3 in vivo studies in CD-1 mice: a host-mediated assay, cytogenic study, and dominant lethal assay.

    Impairment of Fertility

    Fertility studies of YUVEZZI or carbachol have not been conducted.

    A reproduction and fertility study in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at oral doses up to 1 mg/kg.

  • 14 CLINICAL STUDIES

    The efficacy of YUVEZZI for the treatment of presbyopia was demonstrated in two Phase 3, randomized, double‐masked, controlled studies in participants 45 to 80 years old with presbyopia. BRIO I was a crossover study in which 182 participants received a single administration of 1 drop of YUVEZZI, carbachol, and brimonidine tartrate in each eye with at least 3 days between treatments and was designed to evaluate the superiority of YUVEZZI over either active monotherapy. In BRIO II, 436 participants were randomized for a single administration of 1 drop of YUVEZZI or vehicle (218 to each group) in each eye. In addition, participants administered 1 drop of YUVEZZI or vehicle once daily for 6 months followed by a 6-month open-label extension. Both studies included participants who were post-refractive surgery and/or pseudophakic.

    The proportions of participants achieving a gain from baseline of 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) under mesopic conditions were evaluated.

    Table 1 demonstrates the effect on presbyopia, from 30 minutes post dose to 8 hours.

    Table 1. Proportion of participants from BRIO I and BRIO II studies achieving a gain from baseline of 3 lines (15 letters) or more in BUCNVA without a loss of 1 line (5 letters) or more in BUCDVA
    TimepointBRIO IBRIO II
    YUVEZZI
    (N=182)     		Brimonidine tartrate
    (N=182)     		Carbachol
    (N=182)     		YUVEZZI
    (N=218)     		Vehicle
    (N=218)
    P-values are for comparisons to YUVEZZI.
    Abbreviations: N: number of participants in the study arm.
    Hour 0.527.0%10.8%
    (p<0.01)     		24.9%
    (p=0.54)     		19.4%1.8%
    (p<0.01)
    Hour 149.4%22.7%
    (p<0.01)     		35.0%
    (p<0.01)     		38.2%3.7%
    (p<0.01)
    Hour 251.1%26.7%
    (p<0.01)     		39.8%
    (p<0.01)     		34.1%3.7%
    (p<0.01)
    Hour 432.0%22.2%
    (p=0.02)     		21.6%
    (p=0.01)     		20.3%2.8%
    (p<0.01)
    Hour 622.5%14.8%
    (p=0.04)     		13.7%
    (p<0.01)     		13.8%2.8%
    (p<0.01)
    Hour 813.5%12.5%
    (p=0.73)     		8.6%
    (p=0.10)     		10.2%3.2%
    (p=0.01)
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75% / 0.1% is supplied as a clear, greenish-yellow ophthalmic solution in a low-density polyethylene (LDPE) single-dose vial, as follows:

    Carton box of 30 single-dose vials (6 pouches each containing 5 vials)NDC: 84892-275-30

    Storage

    Store at 36°F to 77°F (2°C to 25°C). Once a pouch is opened, store the single-dose vials in the foil pouch away from light until ready for use. Discard opened single-dose vials and any remaining contents immediately after use.

  • 17 PATIENT COUNSELING INFORMATION

    Night Driving

    Advise patients that they may experience temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination [see Warnings and Precautions (5.1)] .

    Blurred Vision

    Temporary problems when changing focus between near objects and distant objects may occur. Advise patients not to drive or use machinery if vision is not clear [see Warnings and Precautions (5.1)] .

    When to Seek Physician Advice

    Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss [see Warnings and Precautions (5.2)] .

    Contact Lens Wear

    Advise patients to remove contact lenses prior to the instillation of YUVEZZI. Wait 10 minutes after dosing before reinserting contact lenses [see Dosage and Administration (2.2)] .

    Potential for Eye Injury or Contamination of the Product

    Advise patients to avoid touching the tip of the single-dose vial to the eye, eyelids, or to any other surface to prevent eye injury or contamination [see Warnings and Precautions (5.5)] . Advise patients to discard the opened single-dose vial and any remaining contents immediately after use.

    Concomitant Topical Ocular Therapy

    Advise patients that if more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart [see Dosage and Administration (2.2)] .

  • SPL UNCLASSIFIED SECTION

    Manufactured for: Visus Therapeutics, Inc., an affiliate of Tenpoint Therapeutics, Ltd., Seattle, Washington, 98109, USA.

    © 2026 Visus Therapeutics, Inc.

    YUVEZZI and BRIO are trademarks of Visus Therapeutics, Inc.

    Tenpoint is a trademark of Tenpoint Therapeutics Holding Limited.

  • PRINCIPAL DISPLAY PANEL - 0.16 mL Vial Pouch Carton

    NDC: 84892-275-30

    YUVEZZI™
    (carbachol and brimonidine tartrate
    ophthalmic solution) 2.75%/0.1%

    Rx Only

    For topical ophthalmic use

    6 pouches each containing 5 single-dose vials (0.16 mL each)

    tenpoint
    THERAPEUTICS

    PRINCIPAL DISPLAY PANEL - 0.16 mL Vial Pouch Carton
  • INGREDIENTS AND APPEARANCE
    YUVEZZI 
    carbachol and brimonidine tartrate solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 84892-275
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBACHOL (UNII: 8Y164V895Y) (CARBAMOYLCHOLINE - UNII:54Z8M50D6Q) CARBACHOL27.5 mg  in 1 mL
    BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE) BRIMONIDINE TARTRATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 84892-275-306 in 1 CARTON02/18/2026
    1NDC: 84892-275-025 in 1 POUCH
    1NDC: 84892-275-010.16 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC: 84892-275-991 in 1 CARTON02/18/2026
    2NDC: 84892-275-025 in 1 POUCH
    2NDC: 84892-275-010.16 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA22014202/18/2026
    Labeler - Visus Therapeutics, Inc. (117431652)

    • Trademark Results [YUVEZZI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    YUVEZZI
    YUVEZZI
    97760492 not registered Live/Pending
    Visus Therapeutics Inc.
    2023-01-19
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