👁️image loading
(from DailyMed)

YUVEZZI carbachol and brimonidine tartrate 27.5 mg/mL; 1 mg/mL Solution/ Drops

by Visus Therapeutics, Inc. · 6 POUCH in 1 CARTON (84892-275-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01)
NDC 84892-0275-30
🏷️ FDA NDC (as labeled) 84892-275-30 billing pads the product segment with a zero
This package
Contains.16 mL in 1 vial, single-dose Pack sizes2 compare ↓
Also comes in: 1 pouch 84892-0275-99
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 84892-275-30
Product NDC 84892-275
11-digit billing NDC 84892027530
NCPDP billing unit EA — each (per item)
RxCUI 2736933, 2736939
UNII 8Y164V895Y, 4S9CL2DY2H
UPC 0384892275303
Application # NDA220142
SPL Set ID 68198098-0f33-458f-83b8-eb2a5ec69012
Established class (EPC) Cholinergic Receptor Agonist; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Cholinergic Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-18
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CARBACHOL; BRIMONIDINE TARTRATE
GCN Seq No 088596
GCN 42389
HICL code 051111
Ingredient (HICL) Carbachol/Brimonidine Tartrate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.20.00
AHFS class Miotics
FDB label name YUVEZZI 2.75%-0.1% EYE DROP
FDB brand name Yuvezzi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 84892-275-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84892-0275-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Other dermatologicals, Sympathomimetics in glaucoma therapy, Sympathomimetics used as decongestants
How it works Adrenergic alpha-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerVisus Therapeutics, Inc.
Application holderVISUS THERAPEUTICS INC
FDA applicationNDA220142 (NDA)
Labeler code84892
First marketedFeb 2026
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name YUVEZZI 2.75%-0.1% EYE DROP Ingredient Carbachol/Brimonidine Tartrate
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 pouch
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Yuvezzi 27.5 mg/mL; 1 mg/mLthis 84892-0275-30 Visus 6 pouches FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
First FDA approval
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 28, 2026 RLD RS ⏳ ~16.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12268662 — method of use (U-3741)
US 12268662 — method of use (U-4419)
US 12268662 — method of use (U-4420)
US 8455494 — method of use (U-3741)
US 8455494 — method of use (U-4419)
US 8455494 — method of use (U-4420)
Exclusivity NP
2026 2028 2030 2032 2034 2036 2038 2040 2042
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 12268662 ↗ Method of use U-3741 Nov 10, 2042
US 12268662 ↗ Method of use U-4419 Nov 10, 2042
US 12268662 ↗ Method of use U-4420 Nov 10, 2042
US 8455494 ↗ Method of use U-3741 May 24, 2030
US 8455494 ↗ Method of use U-4419 May 24, 2030
US 8455494 ↗ Method of use U-4420 May 24, 2030
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJan 28, 2029
Common questions
Is there a generic version of YUVEZZI 2.75%-0.1% EYE DROP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for YUVEZZI 2.75%-0.1% EYE DROP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2042 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for YUVEZZI (this brand).

Top reported reactions

Headache17
Nausea8
Dizziness6
Eye Pain5
Eye Irritation4
Vision Blurred4
Migraine3

Reporter sex

38 reports
Male · 25%
Female · 75%
Reports over time (by year) — tap or hover for the count & year
2025 2026 38 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84892-0275-30 You're viewing this 6 POUCH in 1 CARTON (84892-275-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) 2026-02-18 Active
84892-0275-99 1 POUCH in 1 CARTON (84892-275-99) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) 2026-02-18 Active

Pack size FAQ

What quantity is in NDC 84892-0275-30?
NDC 84892-0275-30 is listed by the FDA — 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .16 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of YUVEZZI carbachol and brimonidine tartrate 27.5 mg/mL; 1 mg/mL Solution/ Drops?
Bill NDC 84892-0275-30 — the 11-digit billing format is 84892027530. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 84892-275-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84892-0275-30, written without dashes as 84892027530. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84892-0275-30, the first segment (84892) is the labeler code FDA assigned to Visus Therapeutics, Inc.; the middle segment (0275) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Visus Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 pouch (84892-0275-99). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Visus Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 40 words

1 INDICATIONS AND USAGE YUVEZZI™ is indicated for the treatment of presbyopia in adults. YUVEZZI is a combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, indicated for the treatment of presbyopia in adults. ( 1 )

⏱️ Dosage and Administration 93 words

2 DOSAGE AND ADMINISTRATION Instill one drop in each eye once daily. ( 2.1 )

2.1Recommended Dosage The recommended dosage of YUVEZZI is one drop in each eye once daily.

2.2Administration 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.

💊 Dosage Forms and Strengths 41 words

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. Ophthalmic solution: carbachol 2.75% and brimonidine tartrate 0.1% in a single-dose vial. ( 3 )

Contraindications 24 words

4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Blurred Vision : Advise patients not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal tear and detachment have been reported with miotics.

Individuals with preexisting retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.

( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) Potentiation of Vascular Insufficiency : Use with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. ( 5.4 )

5.1Blurred 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.

5.2Risk 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.

5.3Iritis 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.

5.4Potentiation 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.

5.5Potential 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.

🤒 Adverse Reactions 205 words

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications (4) ] Most common adverse reactions (incidence >5%) are eye pain upon instillation, visual impairment, eye irritation upon instillation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Visus Therapeutics, Inc., at 1-888-735-0821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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.

🔄 Drug Interactions ~1 min read

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 )

7.1Antihypertensives/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.

7.2CNS 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.

7.3Tricyclic 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.

7.4Monoamine 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.

👥 Use in Specific Populations ~2 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.4Pediatric Use Presbyopia does not occur in the pediatric population.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.

🤰 Pregnancy ~2 min read

8.1Pregnancy 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.

🧒 Pediatric Use 11 words

8.4Pediatric Use Presbyopia does not occur in the pediatric population.

🧓 Geriatric Use 18 words

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and adult patients.

🆘 Overdosage 105 words

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.

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics 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 max and T max up to 0.066 ng/mL and 0.52 hours respectively. Carbachol plasma concentrations were quantifiable in 6 of 14 subjects, with C max and T max up 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.

🧬 Mechanism of Action 87 words

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 86 words

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.

📦 Storage and Handling 40 words

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.

📋 Description 168 words

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 6 H 15 ClN 2 O 2 . Its structural formula is: 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 15 H 16 BrN 5 O 6 . Its structural formula is: 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.

Chemical Structure Chemical Structure

💬 Information for Patients ~1 min read

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) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.