Home LENZ Therapeutics Announces FDA Approval of Vizz™ (Aceclidine Ophthalmic Solution) 1.44% for Presbyopia Treatment

LENZ Therapeutics Announces FDA Approval of Vizz™ (Aceclidine Ophthalmic Solution) 1.44% for Presbyopia Treatment

Aug 01, 2025 08:18 CST Updated 08:18
LENZ Therapeutics

Ophthalmic Drug Product Developer

LENZ Therapeutics today announced that the U.S. FDA has approved Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in adult patients.According to the press release, Vizz is the first eye drop based on aceclidine for the treatment of presbyopia in adults. Patients use it once daily, with effects lasting up to 10 hours!


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Presbyopia: A Common Age-Related Vision Decline Impacting Nearly 2 Billion Worldwide


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▲ The Scientific Basis of Pupil Constriction for Improving Vision in Presbyopia Patients (Image Source: Reference [2])


Vizz is a preservative-free, once-daily eye drop designed to provide patients with clear near vision for up to 10 hours. The active ingredient in this treatment is aceclidine.Aceclidine is a small-molecule acetylcholine receptor agonist that can cause pupil constriction to less than 2 millimeters, producing a pinhole effect, thereby improving near vision.But compared with other cholinergic receptor agonists, it has more specificity in its action on the iris muscles that control pupil size, thereby reducing pupil constriction while minimizing the contraction of the ciliary muscle, decreasing changes in the refractive power of the lens, and thus avoiding impacts on the patient's distance vision.


The approval of Vizz is primarily based on three randomized, double-blind, controlled Phase 3 clinical studies. CLARITY 1 and CLARITY 2 aimed to evaluate the safety and efficacy of once-daily use of Vizz in 466 subjects over 42 days; CLARITY 3 was conducted in 217 subjects over six months, mainly assessing the long-term safety of the drug.


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Image Source: 123RF


In the CLARITY 1 and CLARITY 2 studies,Vizz met all primary and secondary endpoints for near vision improvement, with results showing it can take effect within 30 minutes and continuously improve vision for up to 10 hours.The near vision improvement results in the two studies showed a high degree of consistency and reproducibility. Vizz demonstrated good tolerability over more than 30,000 days of cumulative use across the three CLARITY studies, with no serious treatment-related adverse events observed. The most common adverse reactions included instillation site irritation, dimmed vision, and headache, most of which were mild, transient, and self-resolving.



References:

[1] LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia. Retrieved July 31, 2025 from https://www.globenewswire.com/news-release/2025/07/31/3125400/0/en/LENZ-Therapeutics-Announces-US-FDA-Approval-of-VIZZ-for-the-Treatment-of-Presbyopia.html

[2] LENZ Therapeutics Corporate Presentation. Retrieved November 1, 2021, from https://lenz-tx.com/wp-content/uploads/2021/10/LENZ_corporate_presentation_for_website.pdf


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