Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 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.
Like all medications, Vizz can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: