Vizz (Aceclidine): Uses, Dosage, Side Effects & Warnings

Uses

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

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.

Dosage forms and strengths

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 ).

Contraindications

None. None.

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.

Side effects

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.

Use in specific populations

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. Systemic levels of aceclidine and its metabolites following topical ocular administration are low [see Clinical Pharmacology (12.3) ] , and it is not known whether measurable levels of aceclidine or its metabolites would be present in human milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIZZ and any potential adverse effects on the breastfed child from VIZZ or from the underlying maternal condition. 8.4 Pediatric Use Presbyopia does not occur in the pediatric population. 8.5 Geriatric Use No overall differences in safety or effectiveness of VIZZ have been observed between patients 65 years of age and older and younger adult patients.

Pregnancy

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).

Pediatric use

8.4 Pediatric Use Presbyopia does not occur in the pediatric population.

Geriatric use

8.5 Geriatric Use No overall differences in safety or effectiveness of VIZZ have been observed between patients 65 years of age and older and younger adult patients.

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.

Description

(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

Mechanism of action

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.

How supplied

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.

Storage

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.

Patient 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) ] .

Active ingredients

Aceclidine Hydrochloride in 1 product

Vizz NDC products (1)

NDC	Strength & form	Labeler	Type
84226-100	Aceclidine Hydrochloride 14.66 mg/mL Solution/ Drops	LENZ Therapeutics, Inc.	NDA

Frequently asked questions

What is Vizz 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 ).

What are the side effects of Vizz?

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… See the full label for the complete list.

Who makes Vizz?

Vizz is listed by 1 labeler in the FDA NDC directory, including LENZ Therapeutics, Inc..