NDC 0074-7098 Vuity
Pilocarpine Hydrochloride Solution/ Drops Ophthalmic

Product Information

Vuity is a human prescription drug product labeled by Abbvie Inc.. The generic name of Vuity is pilocarpine hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Product Code0074-7098
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Vuity
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Pilocarpine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Abbvie Inc.
Labeler Code0074
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA214028
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-28-2021
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Vuity?


Product Packages

NDC 0074-7098-01

Package Description: 1 BOTTLE in 1 BOX > 5 mL in 1 BOTTLE

NDC 0074-7098-03

Package Description: 3 BOTTLE in 1 BOX > 5 mL in 1 BOTTLE

NDC 0074-7098-04

Package Description: 1 BOTTLE in 1 CARTON > 5 mL in 1 BOTTLE

Price per Unit: $28.29364 per ML

NDC 0074-7098-05

Package Description: 1 BOTTLE in 1 CARTON > 1.5 mL in 1 BOTTLE

Product Details

What are Vuity Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Vuity Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Vuity Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Vuity Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



1  Indications And Usage



VUITY is indicated for the treatment of presbyopia in adults.


2  Dosage And Administration



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

If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.


3  Dosage Forms And Strengths



VUITY (pilocarpine hydrochloride ophthalmic solution) is provided as a 1.25% solution (12.5 mg/mL).


4  Contraindications



VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.


5.1  Poor Illumination



Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear.


5.2  Risk Of Retinal Detachment



Rare cases of retinal detachment have been reported with other miotics when used in susceptible individuals and those with pre-existing retinal disease. Patients should be advised to seek immediate medical care with sudden onset of vision loss.


5.3  Iritis



VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.


5.4  Use With Contact Lenses



Contact lens wearers should be advised to remove their lenses prior to the instillation of VUITY and to wait 10 minutes after dosing before reinserting their contact lenses.


5.5  Potential For Eye Injury Or Contamination



To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.


6  Adverse Reactions



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

  • Hypersensitivity [see Contraindications (4)]

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.

VUITY was evaluated in 375 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in >5% of patients were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1-5% of patients were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation.


8.1  Pregnancy



Risk Summary

There are no adequate and well-controlled studies of VUITY administration in pregnant women to inform a drug-associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses.  

Data

Human Data

No adequate and well-controlled trials of VUITY have been conducted in pregnant women. In a retrospective case series of 15 women with glaucoma, 4 patients used ophthalmic pilocarpine either pre-pregnancy, during pregnancy or postpartum. There were no adverse effects observed in patients or in their infants.

Animal Data

In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 970-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.015 mg/kg/day, on a mg/m2 basis).

In a peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 390-fold higher than the MRHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18 mg/kg/day (approximately 200 times the recommended human daily dose of VUITY).


8.2  Lactation



Risk Summary

There is no information regarding the presence of pilocarpine in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of VUITY to an infant during lactation.

Pilocarpine and/or its metabolites are excreted in the milk of lactating rats. Systemic levels of pilocarpine following topical ocular administration are low [see Clinical Pharmacology (12.3)], and it is not known whether measurable levels of pilocarpine 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 VUITY and any potential adverse effects on the breastfed child from VUITY.

Data

Animal Data

Following a single oral administration of 14C-pilocarpine to lactating rats, the radioactivity concentrations in milk were similar to those in plasma. 


8.4  Pediatric Use



Presbyopia does not occur in the pediatric population.


8.5  Geriatric Use



Clinical studies of VUITY did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger patients.


10  Overdosage



Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity. Accidental ingestion can produce sweating, salivation, nausea, tremors and slowing of the pulse 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, atropine, the pharmacologic antagonist to pilocarpine, should be used.


11  Description



VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25%  is a cholinergic muscarinic receptor agonist prepared as an isotonic, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C11H16N2O2 · HCl. Its structural formula is:

Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary.


12.1  Mechanism Of Action



Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. VUITY contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. VUITY also contracts the ciliary muscle and may shift the eye to a more myopic state.


12.3  Pharmacokinetics



Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of VUITY in each eye once daily for 30 days. The mean Cmax and AUC0-t,ss values on Day 30 were 1.95 ng/mL and 4.14 ng·hr/mL, respectively. The median Tmax value on Day 30 was 0.3 hours postdose with a range from 0.2 to 0.5 hours postdose. 


13.1  Carcinogenesis, Mutagenesis, Impairment Of Fertility



Carcinogenesis

Pilocarpine did not induce tumors in mice at any dosage level studied (up to 30 mg/kg/day; approximately 160-times the MRHOD). In rats, an oral dose of 18 mg/kg/day (approximately 200 times the MRHOD), resulted in a statistically significant increase in the incidence of benign pheochromocytomas in both male and female rats, and a statistically significant increase in the incidence of hepatocellular adenomas in female rats.

Mutagenesis

Pilocarpine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations; 2) an in vitro chromosome aberration assay in a Chinese hamster ovary cell line; 3) an in vivo chromosome aberration assay (micronucleus test) in mice; and 4) a primary DNA damage assay (unscheduled DNA synthesis) in rat hepatocyte primary cultures.

Impairment of Fertility

Pilocarpine oral administration to male and female rats at a dosage of 18 mg/kg/day (200 times the recommended human daily dose) resulted in impaired reproductive function, including reduced fertility, decreased sperm motility, and morphologic evidence of abnormal sperm. It is unclear whether the reduction in fertility was due to effects on males, females, or both. In dogs, exposure to pilocarpine at a dosage of 3 mg/kg/day for 6 months resulted in evidence of impaired spermatogenesis (approximately 110 times the recommended human daily dose).


14  Clinical Studies



The efficacy of VUITY for the treatment of presbyopia was demonstrated in two 30‐Day Phase 3, randomized, double‐masked, vehicle‐controlled studies, namely GEMINI 1 (NCT03804268) and GEMINI 2 (NCT03857542). A total of 750 participants aged 40 to 55 years old with presbyopia were randomized (375 to VUITY group) in two studies and participants were instructed to administer one drop of VUITY or vehicle once daily in each eye.

In both studies, the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA), without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction was statistically significantly greater in the VUITY group compared to the vehicle group at Day 30, Hour 3 (see Table 1).

Table 1: Primary Efficacy Results from GEMINI 1 and GEMINI 2 Studies (Intent-to-Treat Population)
GEMINI 1GEMINI 2
VUITY 
N=163
Vehicle
N=160
p-valueVUITY
N=212
Vehicle
N=215
p-value
Proportion of participants gaining 3-lines or more in mesopic DCNVA, without losing more than 1 line (5 letters) of CDVA at Day 30, Hour 3 31%
8%p<0.0126%
11%p<0.01

Figures 1 and 2 present the proportion of participants who gained 3-lines or more in mesopic DCNVA at Day 30.

Figure 1: Proportion of Participants Achieving 3-Lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 1 (Intent-to-Treat Population)Figure 2: Proportion of Participants Achieving 3-lines or More Improvement in Mesopic, High Contrast, Binocular DCNVA at Day 30 in GEMINI 2 (Intent-to-Treat population)

16 How Supplied/Storage And Handling



VUITY is supplied as a sterile ophthalmic solution in colorless low density polyethylene (LDPE) ophthalmic dispenser bottles and tips, with dark green high impact polystyrene caps as follows:

2.5 mL fill in 5 mL bottle (Box containing 1 bottle)NDC 0074-7098-01
2.5 mL fill in 5 mL bottle (Box containing 3 bottles)NDC 0074-7098-03
2.5 mL fill in 5 mL bottle (Carton)NDC 0074-7098-04

Storage

Store at 15°C to 25°C (59°F to 77°F). After opening, VUITY can be used until the expiration date on the bottle.


17  Patient Counseling Information



Night Driving

Caution is advised with night driving and when hazardous activities are undertaken in poor illumination. [see Warnings and Precautions (5.1)]

Accommodative Spasm

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 vision loss. [see Warnings and Precautions (5.2)]

Contact Lens Wear

Contact lens should be removed prior to the instillation of VUITY. Wait 10 minutes after dosing before reinserting contact lenses. [see Warnings and Precautions (5.4)]

Avoiding Contamination of the Product

Do not touch dropper tip to any surface, as this may contaminate the contents. [see Warnings and Precautions (5.5)]

Concomitant Topical Ocular Therapy

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

Distributed by: Allergan, an AbbVie Company
Manufactured for:
AbbVie Inc.
North Chicago, IL 60064 USA
Allergan is an affiliate of AbbVie Inc. 

© 2021 Allergan, an AbbVie Company. North Chicago, IL, 60064, USA

Patented.

v1.0USPI7098


Principal Display Panel



NDC 0074-7098-01

Vuity 

(pilocarpine HCI ophthalmic solution) 1.25%

Contains one 2.5 mL bottle

Rx Only

Sterile

For topical application in the eye

1 x 2.5 mL

Allergan

An AbbVie company

NDC 0074-7098-03

Vuity 

(pilocarpine HCI ophthalmic solution) 1.25%

Contains one 2.5 mL bottle

Rx Only

Sterile

For topical application in the eye

3 x 2.5 mL

Allergan

An AbbVie company

NDC 0074-7098-04

Vuity 

(pilocarpine HCI ophthalmic solution) 1.25%

Rx Only

Sterile

2.5 mL

For topical Application in the Eye

Allergan

An AbbVie company

NDC 0074-7098-05

Professional Sample Not for Resale

Vuity 

(pilocarpine HCI ophthalmic solution) 1.25%

Rx Only

Sterile

1.5 mL

For topical Application in the Eye

Allergan

An AbbVie company


* Please review the disclaimer below.