Pharm'Up 
LENZ Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VIZZ (aceclidine ophthalmic solution) 1.44%, marking it as the first and only FDA-approved eye drop utilizing aceclidine to treat presbyopia in adults. This innovative treatment is expected to be available as samples in the United States starting in October 2025, with widespread commercial availability planned for mid-Q4 2025. LENZ Therapeutics will immediately begin direct-to-eye care professional sales and marketing efforts to introduce this groundbreaking solution.
Eef Schimmelpennink, President and CEO of LENZ Therapeutics, stated, “The FDA approval of VIZZ is a pivotal achievement for our company and a significant advancement for the 128 million adults in the U.S. affected by presbyopia’s blurry near vision. We are thrilled to introduce the first once-daily eye drop proven to enhance near vision for up to 10 hours. This milestone reflects the dedication of our team, partners, clinical investigators, and trial participants, all of whom played a critical role in bringing VIZZ to market.”
VIZZ leverages aceclidine, a novel chemical entity in the U.S., distinguished by its unique pupil-selective miotic action. By targeting the iris sphincter muscle, VIZZ creates a pinhole effect, achieving a sub-2mm pupil size that enhances depth of focus and significantly improves near vision without inducing a myopic shift. This mechanism offers a distinct advantage over existing treatments, making VIZZ a global first in presbyopia management.
Marc Bloomenstein, OD, FAAO, a clinical investigator at Schwartz Laser Eye Care Center in Scottsdale, Arizona, commented, “This approval introduces a game-changing option for the millions struggling with age-related near vision loss. VIZZ offers eye care professionals a highly effective, patient-friendly solution that is poised to become the new standard of care for presbyopia.”
The FDA’s approval was supported by data from three Phase 3 clinical trials: CLARITY 1, CLARITY 2, and CLARITY 3. CLARITY 1 and 2 were randomized, double-masked, controlled studies involving 466 participants who received once-daily doses of VIZZ for 42 days. These trials evaluated the safety and efficacy of VIZZ, meeting all primary and secondary endpoints for near vision improvement. Results showed that VIZZ improved near vision within 30 minutes, with effects lasting up to 10 hours, consistently across both studies. CLARITY 3, a 6-month study with 217 participants, further confirmed VIZZ’s long-term safety.
Across the three CLARITY trials, encompassing over 30,000 treatment days, VIZZ demonstrated a favorable safety profile with no serious treatment-related adverse events. The most frequently reported side effects were mild, transient, and self-resolving, including installation site irritation, dim vision, and headache.
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