VIZZ is indicated for the treatment of presbyopia in adults.

VIZZ is a clear to opalescent and colorless to slightly yellow ophthalmic solution containing 1.44% of aceclidine in a single-dose vial.

None.

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.

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

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 anti-microbial preservatives.

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.

Figure 1 and Figure 2 demonstrate the onset of the VIZZ effect on presbyopia, from 30 minutes post dose and lasting 10 hours.

VIZZ

Sterile | Rx only | For topical application in the eye

NDC 84226-100-11