VIZZ
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- VIZZ
- Generic name
- ACECLIDINE
- Manufacturer
- LENZ Therapeutics, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7aed8024-ad30-44d6-8f3b-63338ad3ce52
- SPL ID
- 485ee479-310b-1721-e063-6394a90aed7d
- Version
- 6
- Effective date
- 2026-01-14
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:38:38
| Harmonized routes |
|---|
| OPHTHALMIC |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 218585 | derived:openfda.application_number |
| application number | NDA218585 | openfda.application_number | |
| brand name | VIZZ | openfda.brand_name | |
| generic name | ACECLIDINE | openfda.generic_name | |
| manufacturer name | LENZ Therapeutics, Inc. | openfda.manufacturer_name | |
| ndc | package | 84226-100-02 | openfda.package_ndc |
| ndc | package | 84226-100-01 | openfda.package_ndc |
| ndc | package | 84226-100-11 | openfda.package_ndc |
| ndc | package | 84226-100-21 | openfda.package_ndc |
| ndc | product | 84226-100 | openfda.product_ndc |
| ndc11 | package | 84226010021 | derived:openfda.package_ndc |
| ndc11 | package | 84226010001 | derived:openfda.package_ndc |
| ndc11 | package | 84226010002 | derived:openfda.package_ndc |
| ndc11 | package | 84226010011 | derived:openfda.package_ndc |
| rxcui | 2721771 | openfda.rxcui | |
| rxcui | 2721776 | openfda.rxcui | |
| spl id | 485ee479-310b-1721-e063-6394a90aed7d | id | |
| spl set id | 7aed8024-ad30-44d6-8f3b-63338ad3ce52 | set_id | |
| unii | 3B22O325Q6 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. 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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.