Aceclidine
FDA Drug Information • Also known as: Vizz
- Brand Names
- Vizz
- Route
- OPHTHALMIC
- Dosage Form
- SOLUTION/ DROPS
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION VIZZ (aceclidine ophthalmic solution) 1.44% is a cholinergic muscarinic receptor agonist supplied as a sterile, clear to opalescent, colorless to slightly yellow, and viscous ophthalmic solution containing 1.75% of aceclidine hydrochloride (equivalent to 1.44% aceclidine). The chemical names for aceclidine hydrochloride are: 1) 3-Acetoxyquinuclidine Hydrochloride; 2) 3-Quinuclidinyl Acetate Hydrochloride. Its molecular weight is 205.68 g/mol and its molecular formula is C 9 H 15 NO 2 ∙ HCl. Each mL of VIZZ contains aceclidine hydrochloride 1.75% (17.82 mg) as the active ingredient. Inactive ingredients in the ophthalmic solution are: polysorbate 80, mannitol, hypromellose, edetate disodium dihydrate, sodium citrate dihydrate, water for injection, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 4.5 and 5.5, if necessary. VIZZ does not contain antimicrobial preservatives. Chemical Structure
What Is Aceclidine Used 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 ).
Dosage and Administration
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.
Side Effects (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.
Contraindications
4 CONTRAINDICATIONS None. None.
Pregnancy and Breastfeeding
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).
Overdosage
10 OVERDOSAGE 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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VIZZ (aceclidine ophthalmic solution) 1.44% is supplied as a sterile, clear to opalescent, colorless to slightly yellow, and viscous ophthalmic solution in configurations of 5 single-dose vials. VIZZ does not include antimicrobial preservatives. Each single-dose vial is comprised of transparent low-density polyethylene (LDPE). 5 single-dose vials are packaged in a foil pouch. VIZZ is supplied in: NDC Number Description Vial Configuration 84226-100-11 carton box of 25 single-dose vials (5 pouches x five vials of 0.4 mL each) 84226-100-21 carton box of 25 single-dose vials (5 pouches x five vials of 0.25 mL each) Figure Figure 16.2 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 refrigeration, VIZZ may be stored at room temperature [up to 77°F (25°C)] but must be used within 30 days. Discard the opened single-dose vial after use. During shipment, VIZZ may be maintained at temperatures up to 104°F (40°C) for a period not exceeding 8 days.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.