Vuity

— THERAPEUTIC CATEGORIES —
  • Miscellaneous ocular agents
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vuity Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pilocarpine HCl 1.25%; oph soln; contains benzalkonium chloride.

    Pharmacological Class

    Cholinergic.

    How Supplied

    Soln—2.5mL, 5mL

    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.

    Manufacturer

    AbbVie

    Generic Availability

    NO

    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. It contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. It also contracts the ciliary muscle and may shift the eye to a more myopic state.

    Vuity Indications

    Indications

    Presbyopia.

    Vuity Dosage and Administration

    Adult

    Instill 1 drop in each eye once daily; may administer a second dose (1 additional drop in each eye) 3–6hrs after the first dose.

    Children

    Not applicable.

    Administration

    If other topical ophthalmic products are being used, administer products at least 5mins apart.

    Vuity Contraindications

    Not Applicable

    Vuity Boxed Warnings

    Not Applicable

    Vuity Warnings/Precautions

    Warnings/Precautions

    Pre-existing retinal disease. Iritis: not recommended. Contact lenses: remove prior to use; reinsert 10mins after administration. Poor illumination: advise to avoid night driving, other hazardous activities. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Blurred Vision

    • May cause accommodative spasm; patients should not drive or operate machinery if vision is blurred.
    • Patients may also experience temporary dim or dark vision with miotics; use caution in night driving and other hazardous activities in poor illumination.

    Risk of Retinal Detachment

    • Cases of retinal detachment and retinal tear have been reported.
    • Individuals with pre-existing retinal disease are at increased risk.
    • Examination of the retina is advised in all patients before starting treatment.

    Iritis

    • Not recommended to be used when iritis is present because adhesions may form between the iris and the lens.

    Contact Lenses

    • Remove lenses before instillation and wait 10 minutes after dosing before reinserting.

    Potential for Eye Injury/Contamination

    • Avoid touching the dispensing bottle to the eye or other surfaces.

    Pregnancy Considerations

    Vuity has not been studied in pregnant women. In a retrospective case series, no adverse effects were observed in 4 women who used ophthalmic pilocarpine pre-pregnancy, during pregnancy, or postpartum for glaucoma treatment.

    Nursing Mother Considerations

    No information is available  regarding the presence of pilocarpine in human milk, the effects on the breastfed infants, or the effects on milk production. Consider the benefits to the mother vs the potential adverse effects on the breastfed child.

    Pediatric Considerations

    Presbyopia does not occur in the pediatric population. 

    Geriatric Considerations

    Clinical trials did not include patients 65 years of age or older to determine whether response is different from younger patients. Clinical experience with ophthalmic pilocarpine suggests no overall differences in safety.

    Vuity Pharmacokinetics

    Absorption

    Vuity Administered as 1 Drop in Each Eye Once Daily for 30 Days

    • The mean (SD) Cmax and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) 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.

    Vuity Administered as 1 Drop in Each Eye Twice Daily for 14 Days

    • The Day 14 mean (SD) Cmax following first daily dosing was 1.81 (0.51) ng/mL and following second daily dosing was 2.12 (1.75) ng/mL. 

    • The Day 14 mean (SD) AUC over 6-hour postdose following first daily dose was 4.35 (1.50) ng·hr/mL and following second daily dose was 4.22 (3.14) ng·hr/mL. There was no significant systemic drug accumulation over time, with accumulation index ratios between Day 1 and Day 14 based on AUC as 1.42 and 1.03 for the first and second daily dose, respectively.

    Vuity Interactions

    Interactions

    Separate with other topical ophthalmic products by at least 5mins apart.

    Vuity Adverse Reactions

    Adverse Reactions

    Headache, conjunctival hyperemia; blurred vision; rare: retinal detachment, retinal tear.

    Vuity Clinical Trials

    Clinical Trials

    Approval was based on data from the phase 3 GEMINI 1 (ClinicalTrials.gov Identifier: NCT03804268) and GEMINI 2 (ClinicalTrials.gov Identifier: NCT03857542) studies that evaluated the efficacy and safety of Vuity in a total of 750 patients aged 40 to 55 years with presbyopia. Patients were randomly assigned 1:1 to receive Vuity or vehicle, 1 drop once daily into each eye.

    Results from the GEMINI 1 and GEMINI 2 studies showed that 31% and 26% of patients treated with Vuity, respectively, met the primary endpoint achieving 3-lines or more in mesopic, high contrast, binocular distance corrected near visual acuity, without losing more than 1 line (5 letters) of corrected distance visual acuity with the same refractive correction on day 30 at hour 3, compared with 8% and 11% of patients in the vehicle group (P <.01).

    The treatment was found to work as early as 15 minutes and lasted up to 6 hours, as measured on day 30.

    Vuity Note

    Not Applicable

    Vuity Patient Counseling

    Patient Counseling

    Exercise caution when night driving and when hazardous activities are undertaken in poor illumination.

    Temporary problems when changing focus between near and distant objects may occur.

    Sudden onset of flashing lights, floaters, or vision loss: Seek immediate medical care.

    Remove contact lenses before instilling drops; wait 10 minutes before reinserting contact lenses.

    Avoid contaminating the product; do not touch dropper top to any surface.

    If multiple ophthalmic products are being used, separate instillation by 5 minutes.

    Cost Savings Program

    Vuity Savings Program

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