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.
There are no adequate and well-controlled studies on the use of VIZZ in pregnant women to determine any drug-associated risks. However, in animal reproduction studies, the oral administration of aceclidine to pregnant rats and rabbits during organogenesis and lactation did not show any adverse effects on the mother, fetus, or neonate at clinically relevant doses.
There is no information available regarding the presence of VIZZ or its metabolites in human or animal milk, its effects on a breastfed infant, or its effects on milk production. While systemic levels of aceclidine and its metabolites are low after topical ocular administration, it is not known if they would be present in human milk.
None.
Patients should be cautioned that VIZZ may cause accommodative spasm, leading to blurred, dim, or dark vision. This can impair the ability to drive or operate machinery, and caution is advised during night driving or other activities in poor illumination.
Although rare, retinal tears and detachments have been reported with the use of miotics, particularly in susceptible individuals with pre-existing retinal disease. A retinal examination is advised for all patients before starting therapy. Patients should be instructed to seek immediate medical care if they experience a sudden onset of flashing lights, floaters, or vision loss. Caution is also advised in patients with a history of iritis, as miotic use may exacerbate ocular inflammation sequelae.
To avoid eye injury and contamination, users must not touch the vial tip to the eye or any other surface. Contact lenses should be removed prior to instillation and may be reinserted after 10 minutes.
Based on clinical trial data, the most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%). Other adverse reactions reported in over 5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of these side effects were reported as mild, transient, and self-resolving