The U.S. Food and Drug Administration (FDA) has approved aceclidine ophthalmic solution (VIZZ™, 1.44%). It is the first and only FDA-approved VIZZ eye drop for the treatment of adults with presbyopia. It is manufactured by LENZ Therapeutics, Inc., a biopharmaceutical company. Presbyopia is the age-related loss of near vision, affecting nearly all adults over 45 years. It is caused by the reduced lens elasticity and leads to difficulty in focusing on close objects. Symptoms often become noticeable in the mid-40s, promoting reliance on reading glasses or other corrective options, often prescribed by ophthalmologists or self-managed.
VIZZ contains a single active ingredient called aceclidine, which is a novel chemical entity in the U.S. Its pupil-selective mechanism of action distinguishes it from other treatments. This chemical entity primarily targets the iris sphincter muscle, creating a pinhole effect as well as reducing the pupil size to under 2mm. This effect increases the depth of focus, significantly improving near vision without inducing a myopic shift. Unlike other miotic agents, this aceclidine minimizes the stimulation of the ciliary muscle and offers a more targeted and better-tolerated treatment option.
This FDA approval was supported by data from Phase 3 randomized, double-blind, controlled clinical trials (CLARITY 1, CLARITY 2, and CLARITY 3). CLARTITY 1 and CLARITY 2 focused on efficacy and safety, involved 466 participants dosed once daily for 42 days. CLARITY 3 estimated the long-term safety in 217 individuals over a 6-month period of daily use.
VIZZ met all primary and secondary outcomes in both CLARITY 1 and CLARITY 2. These trials showed consistent improvement in near vision within 30 minutes of dosing. This effect lasted up to 10 hours. During 30,000 treatment days, this VIZZ therapy was well-tolerated in presbyopia adults and reported no serious adverse reactions. The most frequently reported side effects included headaches, application site irritation, and dim vision. Adverse events like ocular hyperemia (7%) and conjunctival hyperemia (8%) occurred in more than 5% of study participants. These adverse reactions were typically brief and mild, and self-resolving.
Eef Schimmelpennink, President and CEO, LENZ Therapeutics, said, “This FDA approval of VIZZ marks a pivotal milestone for LENZ and a breakthrough for the 128 million U.S. adults with presbyopia. As the first and once-daily eye drop with up to 10 hours of proven efficacy, VIZZ offers a transformative treatment option for blurry near vision. This achievement reflects the collaboration and dedication of the hundreds of trial participants, investigators, our partners, and the LENZ team. We are excited and proud to bring this innovative therapy to the U.S. market and improve the lives of patients nationwide.” Marc Bloomenstein, VIZZ clinical investigator, Schwartz Laser Eye Care Center, Arizona, said that “This FDA approval offers a significant shift in the treatment of presbyopia.
VIZZ represents a highly effective, much-needed solution for age-related near vision and could quickly become standard care for eye care professionals seeking better options for their patients.” Samples of VIZZ should be on the market in the U.S. by October 2025, and the full commercial launch is planned for the middle of the fourth quarter of 2025. The efforts to market and sell to eye care providers will start immediately.
Reference: LENZ Therapeutics, Inc. LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia. Published July 31, 2025. Accessed August 6, 2025. LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia :: LENZ Therapeutics, Inc. (LENZ)
