IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VUITY is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

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