Vizz Drug Information
Generic name: ACECLIDINE
Uses of Vizz
is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults.
Dosage & Administration of Vizz
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.
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 . Discard the opened single-dose vial after use.
Side Effects of Vizz
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.
Warnings & Cautions for Vizz
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.
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.
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.
Hypersensitivity
VIZZ is not recommended for use in patients with a known hypersensitivity to aceclidine or any other ingredient in VIZZ.
Use with Contact Lenses Contact lenses should be removed prior to the
instillation of VIZZ and may be reinserted 10 minutes after instillation.
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.
Pregnancy Safety for Vizz
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 of Vizz
Pediatric Use Presbyopia does not occur in the pediatric population.
Overdosage Information for Vizz
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.
Clinical Studies of Vizz
The efficacy of VIZZ for the treatment of presbyopia was demonstrated in two, randomized, double-masked, controlled studies, CLARITY-1 and CLARITY-2. A total of 466 participants aged 45 to 75 years old with presbyopia were randomized. Participants had a refractive range from -4.00 to +1.00 D sphere, with astigmatism up to 2.00 D, and a spherical equivalent no more myopic than -4.00 D. Both studies included participants who were post-refractive surgery and/or pseudophakic. Participants were instructed to instill 2 drops of VIZZ (or control) in each eye once daily, one drop in each eye followed by a second drop in each eye two minutes later.
Participants were treated for 42 days. Ophthalmic efficacy assessments were conducted on Day 1, Day 15, and Day 28 of the study at various timepoints through 10 hours post dose. In each study, the proportion of participants gaining 3 lines or more in high contrast, distance corrected, near visual acuity (DCNVA) at 40 cm, without loss of 1 line or more (≥5 letters) of distance corrected, distance visual acuity (DCDVA) at 4 meters was statistically significantly greater in the VIZZ group compared to the control group at Day 1, Hour 3. Table 1. Primary Efficacy Endpoint from CLARITY-1 and CLARITY-2 Studies Day 1, at 3 Hours Post Dose (FAS Population) CLARITY-1 CLARITY-2 VIZZ N=157 Brimonidine N=156 p-value VIZZ N=77 Vehicle N=76 p-value Proportion of participants gaining 3-lines or more in DCNVA at 40cm, without losing 1 line or more (≥5 letters) of DCDVA at 4m at Day 1, at 3 hours 65% 12% p<0.01 71% 8% p<0.01 Figure 1 and Figure 2 demonstrate the onset of the VIZZ effect on presbyopia, from 30 minutes post dose and lasting 10 hours.
Figure 1 Percentage of Participants Achieving 3 Lines or More Improvement in High Contrast, Monocular Near Vision (DCNVA at 40 cm) and No Loss of 1 or More Lines (DCDVA at 4 m) on Day 1 at All Measured Time Points (CLARITY-2, FAS population with Observed data) Figure 2 Percentage of Participants Achieving 3 Lines or More Improvement in High Contrast, Monocular Near Vision (DCNVA at 40 cm) and No Loss of 1 or More Lines (DCDVA at 4 m) on Day 1 at All Measured Time Points (CLARITY-1, FAS population with Observed data) Figure 1 Figure 2
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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