Vizz (aceclidine) is filed as cholinergic miotic. The sections below restate public label fields stored for this profile.
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 ).
12.1 Mechanism of Action 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.
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.
4 CONTRAINDICATIONS None. None.
Instillation site irritation (20%); Dim vision (16%); Headache (13%)
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.
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily ( 2 ). 2.1 Recommended Dosage Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily from the same single-dose vial. 2.2 Administration Instructions Contact lenses should be removed prior to the instillation of VIZZ and may be reinserted 10 minutes after instillation. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. To open vial, twist off top [see How Supplied/Storage and Handling (16.1) ] . Discard the opened single-dose vial after use.
17 PATIENT COUNSELING INFORMATION Night Driving Advise patients that they may experience temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination [see Warnings and Precautions (5.1) ]. Blurred Vision Temporary problems when changing focus between near and distant objects may occur. Advise patients not to drive or use machinery if vision is not clear (e.g., blurred vision) [see Warnings and Precautions (5.1) ] . When to Seek Physician Advice Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss [see Warnings and Precautions (5.2) ]. Contact Lens Wear Advise patients to remove contact lenses prior to the instillation of VIZZ. Wait 10 minutes after instillation before reinserting their contact lenses [see Warnings and Precautions (5.5) ]. Potential for Eye Injury or Contamination Advise patients to avoid touching the tip of the single-dose vial to the eye or to any other surface in order to prevent eye injury or contamination [see Warnings and Precautions (5.6) ]. Advise patients to discard the opened single-dose vial and any remaining contents after use. Concomitant Topical Ocular Therapy Advise patients if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart [see Dosage and Administration (2) ] .
According to its FDA label, Vizz (aceclidine) is approved for: 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 ). For medical advice, please talk to your prescriber or pharmacist.
Vizz (aceclidine) belongs to the cholinergic miotic class of medications.
The FDA label lists Vizz (aceclidine) as: 3 DOSAGE FORMS AND STRENGTHS VIZZ is a clear to opalescent and colorless to slightly yellow ophthalmic solution containing 1.44% of aceclidine in a single-dose vial. Ophthalmic solution: aceclidine 1.44% in a single-dose vial ( 3 ).; ophthalmic route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Vizz. Availability changes as patents expire.
Our ingest of the FDA label for Vizz (aceclidine) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Vizz (aceclidine) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Vizz (aceclidine) as 2025-07-31.
The FDA label lists LENZ Therapeutics, Inc. as a labeler/manufacturer of Vizz (aceclidine). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling Store refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. When stored in refrigerated conditions, VIZZ can be used until the expiration date. Once pouch or vial(s) are removed from refrigeratio…" Follow the packaging insert for the authoritative guidance.
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