Aceclidine

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 is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).

• None. None.contraindicated

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.

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.

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.

8.1 Pregnancy 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). 8.2 Lactation 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.

Metabolism

Aceclidine undergoes hydrolysis in the eye to acetate and 3-quinuclidinol (3-Q) with one mole of aceclidine hydrolyzed to one mole of 3-Q. Pharmacokinetic studies are performed on the analysis of 3-Q, which is a metabolite formed from the hydrolysis of aceclidine.

Systemic toxicity following topical ocular administration of miotics is rare, but occasionally patients who are sensitive may develop increased salivation, sweating, gastrointestinal overactivity, and slowing of the pulse. Accidental ingestion can produce sweating, salivation, nausea, tremors, slowing of the pulse, and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration.

• Jul 31, 2025NDANDA218585Lenz Therap

1. 1Ocular Hyperaemia19747%
2. 2Visual Impairment14835%
3. 3Instillation Site Irritation13131%
4. 4Headache10425%
5. 5Drug Effect Less Than Expected4912%
6. 6Vision Blurred4711%
7. 7Drug Ineffective4411%
8. 8Nausea204.8%
9. 9Vitreous Floaters194.5%
10. 10Product Dose Omission In Error153.6%
11. 11Visual Acuity Reduced143.3%
12. 12Condition Aggravated133.1%
13. 13Dizziness133.1%
14. 14Off Label Use133.1%
15. 15Foreign Body Sensation In Eyes122.9%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Aceclidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase 3 Safety Study of LNZ100 and LNZ101 for the Treatment of Presbyopia Subjects
  Completed · Phase 3 · Interventional · 362 enrolled · LENZ Therapeutics, Inc
  NCT05753189updated 2026-05-13
• Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of Presbyopia
  Completed · Phase 3 · Interventional · 469 enrolled · LENZ Therapeutics, Inc
  NCT05656027updated 2026-05-13
• Phase 3 Efficacy Study of LNZ100 & LNZ101 for the Treatment of Presbyopia
  Completed · Phase 3 · Interventional · 229 enrolled · LENZ Therapeutics, Inc
  NCT05728944updated 2026-02-25
• Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
  Completed · Phase 3 · Interventional · 300 enrolled · Corxel Pharmaceuticals
  NCT06045299updated 2025-03-03
• Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia
  Completed · Phase 2 · Interventional · 68 enrolled · LENZ Therapeutics, Inc
  NCT05294328updated 2024-09-05
• Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia
  Completed · Phase 2 · Interventional · 59 enrolled · LENZ Therapeutics, Inc
  NCT05431543updated 2024-09-05
• Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia
  Completed · Phase 1 · Interventional · 21 enrolled · Corxel Pharmaceuticals
  NCT06270030updated 2024-04-23
• Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
  Completed · Phase 1 · Interventional · 30 enrolled · LENZ Therapeutics, Inc
  NCT05936489updated 2023-10-16
• A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
  Completed · Phase 2 · Interventional · 58 enrolled · LENZ Therapeutics, Inc
  NCT03201562updated 2022-09-22
• Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
  Completed · Phase 2 · Interventional · 20 enrolled · LENZ Therapeutics, Inc
  NCT02554396updated 2017-10-23

Frequently asked questions

How does Aceclidine work?

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.

What is Aceclidine used for?

According to FDA labeling, Aceclidine carries indications including: VIZZ is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Aceclidine?

Aceclidine is classified as Parasympathomimetics, Cholinergic Receptor Agonist, Cholinergic Muscarinic Agonists, Pupillary Constriction.

What are the brand names for Aceclidine?

Aceclidine is marketed under brand names including Vizz.

What are the contraindications for Aceclidine?

Aceclidine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.