SAN DIEGO — March 10, 2026
LENZ Therapeutics announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for VIZZ® (aceclidine ophthalmic solution) 1.44%, a prescription eye drop developed to treat presbyopia, an age-related condition that causes difficulty focusing on nearby objects. The regulatory filing marks a major step toward expanding global access to the therapy across Europe and reflects the company’s strategy to establish VIZZ as a first-in-class pharmacological solution for near-vision impairment affecting millions of adults worldwide. The application is supported by robust clinical data from the Phase 3 CLARITY clinical trials, which demonstrated significant improvements in near-vision performance along with a favorable safety profile.
Regulatory Expansion for Innovative Presbyopia Therapy
The EMA submission represents a critical milestone in LENZ Therapeutics’ international regulatory strategy, following the successful approval of VIZZ in the United States by the U.S. Food and Drug Administration in July 2025. The approval established VIZZ as the first and only aceclidine-based eye drop indicated to improve near vision in adults with presbyopia, introducing a new pharmacological option beyond reading glasses or surgical procedures.
Presbyopia is a widespread vision condition that typically begins in middle age and affects the eye’s ability to focus on nearby objects due to age-related changes in the lens and surrounding muscles. Globally, the condition affects more than one billion individuals, creating significant demand for innovative treatment options that restore near vision without invasive procedures or corrective lenses.
The submission to the EMA aims to make VIZZ available to patients throughout the European Union, further strengthening LENZ Therapeutics’ position as a leader in ophthalmology drug innovation. By expanding regulatory filings across multiple regions, the company seeks to accelerate global access to a therapy designed to provide rapid, sustained near-vision improvement through a once-daily eye-drop treatment.
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Clinical Evidence from Phase 3 CLARITY Studies
The regulatory application is supported by data from three randomized, double-masked Phase 3 CLARITY clinical trials, which evaluated the efficacy and safety of aceclidine ophthalmic solution 1.44% in adults diagnosed with presbyopia. The trials demonstrated that the therapy met all primary and secondary endpoints, confirming its ability to significantly improve near vision without compromising distance vision.
Clinical results showed that VIZZ begins improving near vision within approximately 30 minutes after administration, with therapeutic effects lasting up to 10 hours, allowing patients to perform everyday activities such as reading or using digital devices without relying on corrective lenses.
In addition to its rapid onset of action, the therapy demonstrated a strong safety and tolerability profile, with no serious treatment-related adverse events observed during more than 30,000 treatment days across clinical trials. These findings highlight the potential of VIZZ to deliver a reliable and convenient treatment alternative for individuals experiencing age-related near-vision decline.
The unique mechanism of action of aceclidine creates a pupil-selective “pinhole effect”, improving depth of focus and enabling clearer near vision without significantly affecting distance vision. This pharmacological approach represents a novel strategy for managing presbyopia, expanding the therapeutic landscape within ophthalmology.
Expanding Global Access to Vision Innovation
The EMA filing underscores LENZ Therapeutics’ broader global commercialization strategy, which includes partnerships and regulatory submissions in multiple international markets. The company is actively working to make VIZZ accessible worldwide, building on its commercial launch in the United States and expanding regulatory filings in additional regions.
Industry experts view the therapy as part of a growing category of pharmacologic vision-correction technologies, which aim to provide non-surgical solutions for common ocular conditions. With presbyopia affecting a large and expanding aging population, innovative treatments such as aceclidine-based ophthalmic solutions could significantly transform how vision loss is managed in everyday clinical practice.
As regulatory reviews progress in Europe, ophthalmologists and healthcare providers will closely monitor the evaluation process to determine whether VIZZ will become the first aceclidine-based eye-drop therapy approved in the European market. If authorized, the treatment could provide millions of patients with a convenient, fast-acting alternative to reading glasses, helping restore visual independence and improving quality of life.
Through continued investment in ophthalmology innovation, regulatory expansion, and global commercialization, LENZ Therapeutics is positioning itself at the forefront of next-generation vision therapies aimed at addressing one of the most common age-related vision challenges worldwide.
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Source: LENZ Therapeutics press release
