VIZZ Ophthalmic solution Ref.[115527] Active ingredients: Aceclidine

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.

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.

VIZZ dosed once daily was evaluated for safety and efficacy in 466 participants with presbyopia in 2 randomized, double-masked, controlled phase 3 studies for 42 days (CLARITY-1, NCT05656027 and CLARITY-2, NCT05728944). VIZZ dosed once daily was also evaluated for long term safety in 217 participants with presbyopia in a separate randomized, double-masked, controlled phase 3 study (CLARITY-3, NCT05753189) for a 6-month duration.

The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving.

Risk Summary

There are no adequate and well controlled studies of VIZZ administration in pregnant women to inform a drug associated risk. In animal reproduction studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis and lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses.

Data

Animal Data

In embryofetal development studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis produced no maternal toxicity, skeletal anomalies, nor reduction in fetal body weight at 1.5 mg/kg/day (approximately 110-fold and 70-fold the human plasma exposure to the metabolite, 3-quinuclidinol, in rats and rabbits, respectively, at the MRHOD, assuming administration of 2 drops/eye/day).

In a pre-/postnatal development study in rats, oral administration of aceclidine during organogenesis through lactation produced no adverse maternal, fetal, or neonatal effects at doses up to 1.5 mg/kg/day (approximately 110-fold higher than the MHOD based on body surface area, assuming administration of 2 drops/eye/day).

Risk Summary

There is no information regarding the presence of VIZZ or its metabolite in human or animal milk, the effects on breastfed infants or the effects on milk production to inform the risk of VIZZ to an infant during lactation.

Systemic levels of aceclidine and its metabolites following topical ocular administration are low [see Clinical Pharmacology (12.3)], and it is not known whether measurable levels of aceclidine or its metabolites would be present in human milk following topical ocular administration.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIZZ and any potential adverse effects on the breastfed child from VIZZ or from the underlying maternal condition.

Presbyopia does not occur in the pediatric population.

No overall differences in safety or effectiveness of VIZZ have been observed between patients 65 years of age and older and younger adult patients.