ข้อมูลนี้มีวัตถุประสงค์เพื่อการศึกษาเท่านั้น ควรปรึกษาผู้เชี่ยวชาญด้านสุขภาพเสมอ เรียนรู้เพิ่มเติม

Aceclidine

Prescription

ชื่อทางการค้า: VIZZ

รูปแบบยา
Drops
เส้นทางการให้ยา
OPHTHALMIC
ผู้ผลิต
LENZ Therapeutics, Inc.

About This Medication

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

ส่วนประกอบออกฤทธิ์

ส่วนประกอบ ความแรง
Aceclidine Hydrochloride -

ข้อบ่งใช้และการใช้งาน

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 ).

กลไกการทำงาน

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.

ขนาดยาและวิธีการให้ยา

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 Overview

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.

คำเตือนและข้อควรระวัง

ข้อห้ามใช้

เภสัชจลนศาสตร์

12.3 Pharmacokinetics 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 mean C max and AUC 0-t values for 3-Q after Day 8 dosing were 2.114 ng/mL and 4.899 hr*ng/mL, respectively. There was little to no accumulation of 3-Q after repeat once daily dosing of VIZZ. After 8 days, the mean (SD) RAUC 0-t and RC max values were 1.189 (0.770) and 0.996 (0.314), respectively. T 1/2 could not be estimated at any timepoint due to the limited amount of quantifiable 3-Q concentrations after ocular dosing.

Frequently Asked Questions

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 ).

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 …

5 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 …

4 CONTRAINDICATIONS None. None.

Aceclidine is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

ข้อจำกัดความรับผิดชอบทางการแพทย์

ข้อมูลในหน้านี้มีวัตถุประสงค์เพื่อการศึกษาเท่านั้น และไม่ควรใช้แทนคำแนะนำทางการแพทย์จากผู้เชี่ยวชาญ การวินิจฉัย หรือการรักษา

ควรขอคำแนะนำจากแพทย์หรือผู้ให้บริการด้านสุขภาพที่มีคุณสมบัติอื่นๆ เสมอ สำหรับคำถามใดๆ ที่คุณมีเกี่ยวกับภาวะทางการแพทย์หรือยา

แหล่งข้อมูล: DailyMed (NLM), openFDA, MFDS

Medical Disclaimer

This content is for educational and informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making medication decisions.

Data sources: ChEMBL, PubChem, DailyMed.