LENZ Therapeutics Receives FDA Approval for VIZZ, a Novel Eye Drop for Presbyopia Treatment

LENZ Therapeutics has announced FDA approval of VIZZ, the first aceclidine-based eye drop to treat presbyopia, a condition affecting 128 million adults in the US. VIZZ is the first once-daily solution to improve near vision with proven efficacy for up to 10 hours. Samples are expected in the US as early as October 2025, with commercial product availability by mid-Q4 2025.

LENZ Therapeutics, Inc. (NASDAQ: LENZ) has achieved a significant milestone with the FDA approval of VIZZ, a novel eye drop designed to treat presbyopia, a condition affecting approximately 128 million adults in the United States. This approval marks a transformative step for LENZ Therapeutics, positioning the company at the forefront of the presbyopia treatment market.

VIZZ, an aceclidine-based eye drop, is the first and only FDA-approved product of its kind for presbyopia treatment. It is a once-daily solution that provides up to 10 hours of improved near vision, making it a convenient alternative to traditional reading glasses. The product works by contracting the iris sphincter muscle to achieve a sub-2mm pupil without causing myopic shift, a unique mechanism that differentiates it from other treatments.

The FDA approval is based on robust clinical data from three Phase 3 studies (CLARITY 1, 2, and 3) involving 683 participants. These studies demonstrated consistent efficacy within 30 minutes of application and a favorable safety profile, with no serious treatment-related adverse events. The most common adverse reactions were mild and transient, including installation site irritation, dim vision, and headache.

LENZ Therapeutics expects to make samples of VIZZ available in the United States as early as October 2025, with full commercial product availability by mid-Q4 2025. The company is poised to capitalize on this first-mover advantage in the aceclidine space, addressing an unmet need in a condition that impacts nearly every adult as they age.

The approval of VIZZ represents a significant milestone for LENZ Therapeutics, transforming the company from a clinical-stage to a commercial-stage entity. This approval unlocks access to a vast market of approximately 128 million adults in the US suffering from presbyopia. LENZ Therapeutics is well-positioned to become the standard of care in presbyopia treatment, given VIZZ's differentiated profile and proven efficacy.

The FDA approval of VIZZ is a testament to LENZ Therapeutics' commitment to innovation and its ability to develop effective treatments for age-related vision loss. As the company prepares for a robust commercial launch, investors and financial professionals can look forward to the potential growth opportunities that this approval presents.

References:
[1] https://www.stocktitan.net/news/LENZ/lenz-therapeutics-announces-us-fda-approval-of-vizztm-for-the-mw9e8obddrzm.html