aceclidine 14.4 MG/ML Ophthalmic Solution

INDICATIONS AND USAGE VIZZ is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).

DOSAGE AND ADMINISTRATION Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily ( 2 ). 2.1 Recommended Dosage Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily from the same single-dose vial. 2.2 Administration Instructions Contact lenses should be removed prior to the instillation of VIZZ and may be reinserted 10 minutes after instillation. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. To open vial, twist off top [see How Supplied/Storage and Handling (16.1) ] . Discard the opened single-dose vial after use.

WARNINGS AND PRECAUTIONS Blurred Vision: Patients may experience temporary dim or dark vision after instillation. Do not 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 Tear/Detachment: Rare cases of retinal tears and detachments have been reported with miotics. 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 a history of iritis ( 5.3 ). 5.1 Blurred Vision Miotics may cause accommodative spasm. Do not drive or operate machinery if vision is not clear (e.g., blurred vision). Patients may experience temporary dim or dark vision. Exercise caution in night driving and other hazardous activities in poor illumination. 5.2 Risk of Retinal Tear/Detachment Rare cases of retinal tear and detachment have been reported with miotics when used in susceptible individuals and those with pre-existing retinal disease. Examination of the retina is advised in all patients prior to the initiation of treatment with VIZZ. Patients should be advised to seek immediate care with sudden onset of flashing lights, floaters, or vision loss. 5.3 Iritis Sequelae of ocular inflammation, i.e., adhesions (synechiae) between the iris and the lens, may be exacerbated with miotic use in patients with a known history of iritis. 5.4 Hypersensitivity VIZZ is not recommended for use in patients with a known hypersensitivity to aceclidine or any other ingredient in VIZZ. 5.5 Use with Contact Lenses Contact lenses should be removed prior to the instillation of VIZZ and may be reinserted 10 minutes after instillation. 5.6 Potential for Eye Injury or Contamination To prevent eye injury or contamination, care should be taken to avoid touching the single-dose vial to the eye or to any other surface.

CONTRAINDICATIONS None. None.

Mechanism of Action Aceclidine is a cholinergic muscarinic agonist that stimulates muscarinic receptors located on smooth muscles. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision.