Vuity

1 INDICATIONS AND USAGE VUITY ® is indicated for the treatment of presbyopia in adults. VUITY is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults.

The recommended dosage of VUITY is one drop in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

Instill one drop of VUITY in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose.

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. 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. Iritis : Caution is advised in patients with iritis.

5.1Blurred 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.

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

8.1Pregnancy 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 485-fold higher than the maximum human ophthalmic dose [MHOD] of 0.03 mg/kg/day assuming administration of 2 drops/eye/day, on a mg/m 2 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 195-fold higher than the MHOD). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18 mg/kg/day (approximately 100 times the maximum human ophthalmic dose of VUITY).

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Most common adverse reactions (>5%) are headache, conjunctival hyperemia, and eye irritation. To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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.

6.2Postmarketing 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.