VIZZ

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 exposure of aceclidine hydrochloride was evaluated in 16 subjects with presbyopia following once daily VIZZ administration (one drop of VIZZ in each eye followed by a second drop in each eye two minutes later) for 8 days. The ...

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 ...

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 d...

None. None.

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 immed...