VIZZ
Generic: ACECLIDINE
Basic Information
Manufacturer
LENZ Therapeutics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
7aed8024-ad30-44d6-8f3b-63338ad3ce52
Indications & Usage
1 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 ).
VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%) ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact LENZ Therapeutics, Inc.
at 1-888-711-LENZ 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.
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.
To report SUSPECTED ADVERSE REACTIONS, contact LENZ Therapeutics, Inc.
at 1-888-711-LENZ 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.
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.