VUITY

5 WARNINGS AND PRECAUTIONS Blurred Vision : Patients should be advised 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 D etachment : 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 initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss. ( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) 5.1 Blurred Vision 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. 5. 2 Risk of Retinal D etachment 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. 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 )] Most common adverse reactions (>5%) are headache, conjunctival hyperemia, and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 dosed once daily was evaluated in 375 participants 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 participants were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1-5% of participants were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation. VUITY was also evaluated in 114 participants with presbyopia in a randomized, double-masked, vehicle-controlled 14-day study (VIRGO) in which participants received two doses of VUITY in each eye, 6 hours apart daily. The most common adverse reactions reported in >5 % of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters. 6.2 Postmarketing Experience 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.