No
serious AEs were
observed2
For US Healthcare Professionals Only
For US Healthcare Professionals Only
No
serious AEs were
observed2
The majority of treatment-emergent adverse events (TEAEs) were deemed by the investigator to be mild in severity. TEAEs of moderate severity were reported for 4.0% of participants [15/375] in the VUITY® group and 2.4% of participants [9/374] in the vehicle group. Severe TEAEs were reported for 1.1% [4/375] of participants in the VUITY® group and 0.5% [2/374] of participants in the vehicle group.2
Rate of TEAEs in GEMINI 1 and GEMINI 2 (pooled data)1,2
Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY®. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.1
The following adverse reactions have been identified during postapproval use of VUITY®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to VUITY® exposure. Eye disorders: vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.1
VUITY® (pilocarpine hydrochloride ophthalmic solution) 1.25% is indicated for the treatment of presbyopia in adults.
VUITY is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.
Miotics, including VUITY, may cause accommodative spasm. Patients should be advised not to 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, including VUITY. Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination.
Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.
VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and lens.
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.
To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.
The most common adverse reactions (>5%) reported in clinical trials were headache, conjunctival hyperemia, and eye irritation.
Please see full Prescribing Information.
US-VUI-230052
References: 1. VUITY [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on File, ABVRRTl73152.