Lenz Therapeutics Secures FDA Approval for VIZZ for Presbyopia Treatment

Lenz Therapeutics获得FDA批准VIZZ用于治疗老花眼

August 01, 2025

2025年8月1日

Lenz Therapeutics has received U.S. FDA approval for VIZZ (aceclidine ophthalmic solution 1.44%), marking a significant milestone in the treatment of presbyopia. VIZZ is the first and only FDA-approved aceclidine-based eye drop specifically designed to address near vision loss in adults. It is expected to be commercially available in the U.S.

Lenz Therapeutics 已获得美国 FDA 批准的 VIZZ（1.44% 乙酰氯化物眼用溶液），这标志着老花眼治疗的一个重要里程碑。VIZZ 是首款也是唯一一款获 FDA 批准的基于乙酰氯化物的眼药水，专门用于解决成年人的近视力丧失问题。预计它将在美国上市销售。

by Q4 2025, with product sampling anticipated as early as October 2025..

截至2025年第四季度，预计最早将于2025年10月进行产品采样。

FDA Approval Expands Treatment Options for Presbyopia

FDA批准扩大了老花眼的治疗选择

VIZZ introduces a novel, once-daily therapeutic option for the estimated 128 million adults in the U.S. living with blurry near vision due to presbyopia.

VIZZ 为美国约 1.28 亿因老花眼而出现视力模糊的成年人提供了一种新型的每日一次治疗选择。

“This FDA approval of VIZZ is a defining moment for Lenz and represents a transformative improvement in the available treatment options,” said Eef Schimmelpennink, President and CEO of Lenz Therapeutics.

“VIZZ获得FDA批准对Lenz来说是一个决定性的时刻，代表着现有治疗选择的一项变革性改进，”Lenz Therapeutics总裁兼首席执行官Eef Schimmelpennink表示。

He added, “We are ready and excited to launch the first and only once-daily eye drop with proven efficacy for up to 10 hours into the market.”

他补充道：“我们已准备好并兴奋地将首款也是唯一一款每日一次、长达10小时疗效的滴眼液推向市场。”

Differentiated Mechanism of Action

作用机制的差异化

VIZZ operates as a predominantly pupil-selective miotic, targeting the iris sphincter muscle with minimal ciliary muscle stimulation. This mechanism induces a pinhole effect by creating a sub-2mm pupil, which increases depth of focus and improves near vision without inducing a myopic shift, a common drawback of other miotic treatments..

VIZZ主要作为一种选择性缩瞳剂，作用于虹膜括约肌，对睫状肌的刺激较小。该机制通过形成小于2毫米的瞳孔产生针孔效应，从而增加焦深、改善近视力，且不会引起近视漂移，这是其他缩瞳治疗常见的缺点。

The drug’s active ingredient, aceclidine, is a new chemical entity in the U.S. and its approval by the FDA represents a global first for this compound in presbyopia treatment.

这种药物的活性成分乙酰氯胺在美国是一种新的化学实体，其获得FDA批准代表了该化合物在全球范围内首次用于老花眼治疗。

Overview of Phase 3 Clinical Trial Results

第三阶段临床试验结果概述

FDA approval of VIZZ was based on results from three Phase 3 clinical trials. CLARITY 1 and CLARITY 2 were randomized, double-masked, controlled studies that evaluated 466 participants who were dozed once daily over a 42-day period. Both trials successfully met all primary and secondary endpoints, demonstrating that VIZZ improved near vision within 30 minutes of administration, with effects lasting up to 10 hours.

VIZZ获得FDA批准是基于三项III期临床试验的结果。CLARITY 1和CLARITY 2是随机、双盲、对照研究，评估了466名参与者，这些参与者在42天内每日一次使用VIZZ。两项试验均成功达到了所有主要和次要终点，证明VIZZ在给药后30分钟内改善了近视力，效果持续长达10小时。

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CLARITY 3 was a long-term safety study that included 217 participants over a six-month period of once-daily dosing. This trial confirmed the favorable safety profile of VIZZ, with no serious treatment-related adverse events observed across more than 30,000 treatment days.

CLARITY 3 是一项长期安全性研究，包含 217 名参与者，为期六个月，每日一次给药。该试验确认了 VIZZ 良好的安全性，在超过 30,000 个治疗日中未观察到任何严重的治疗相关不良事件。

VIZZ was well-tolerated, with the most commonly reported side effects being instillation site irritation, dim vision, and headache. These reactions were generally mild, transient, and self-resolving.

VIZZ耐受性良好，最常见的副作用是滴注部位刺激、视力模糊和头痛。这些反应通常较轻、短暂且可自行消退。

Clinical and Market Perspectives

临床与市场视角

Dr. Marc Bloomenstein, OD, FAAO, a VIZZ clinical investigator at Schwartz Laser Eye Care Center in Scottsdale, Arizona, commented:

亚利桑那州斯科茨代尔施瓦茨激光眼科中心的VIZZ临床研究员、视光学博士、美国眼科学会会员马克·布卢门斯坦评论道：

“This FDA approval represents a disruptive paradigm shift in treatment options for millions of people who are frustrated and struggling with the inevitable age-related loss of their near vision. I believe this will be a welcome solution for both optometrists and ophthalmologists who will now be able to offer a highly effective and sought-after presbyopia treatment that could immediately become the standard of care, with a product profile that will meet our patients’ needs.”.

“这一FDA批准代表了数百万因年龄增长导致近视力不可避免下降而感到沮丧和挣扎的人们的治疗选择的重大突破性转变。我相信，这将是一个备受欢迎的解决方案，无论是验光师还是眼科医生，现在都可以提供一种高效且备受追捧的老花眼治疗方法，这种方法可能立即成为护理标准，其产品特性将满足我们患者的需求。”

Commercial Rollout Plans

商业推广计划

Lenz Therapeutics plans to begin direct-to-eye care professional sales and marketing immediately. VIZZ samples are expected in October 2025, with full commercial availability by mid-Q4 2025.

Lenz Therapeutics 计划立即开始直接面向眼科护理专业人士的销售和营销。VIZZ 样品预计将在 2025 年 10 月提供，并于 2025 年第四季度中期实现全面商业化供应。