FDA Approves Aceclidine (VIZZ) for Presbyopia in Adults

The US Food and Drug Administration (FDA) has approved aceclidine ophthalmic solution 1.44% (VIZZ) for the treatment of presbyopia in adults.

The approval, which was announced by LENZ Therapeutics Inc. on July 31, 2025, makes aceclidine ophthalmic solution 1.44% the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults. According to LENZ Therapeutics, samples are expected in the US as early as October 2025, with commercial product available by mid-Q4 2025.1

“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,” said clinical investigator Marc Bloomenstein, OD, director of Optometric Services of Schwartz Laser Eye Care Center in Scottsdale, Arizona.1 “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.”

The approval of aceclidine ophthalmic solution 1.44% is based on the CLARITY clinical trial program, which included the CLARITY 1, 2, and 3 trials. CLARITY 1 and CLARITY 2 assessed the safety and efficacy in 466 participants dosed once daily for 42 days. CLARITY 3 evaluated 217 participants for long term safety over a 6-month duration of once-daily dosing.1,2

Both CLARITY 1 and 2 achieved the primary endpoints and key secondary endpoints, with statistically significant 3-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one-line or more in distance visual acuity.2

According to LENZ Therapeutics, aceclidine ophthalmic solution 1.44% boasts a predominantly pupil-selective miotic mechanism of action that interacts with the iris, with minimal ciliary muscle stimulation. Data suggest aceclidine causes contraction of the iris sphincter muscle, which results in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to improve near vision without causing a myopic shift.1

The company also points out aceclidine, the sole active ingredient, is a new chemical entity in the United States and its FDA approval marks a global first in the treatment of presbyopia.1

“The FDA approval of [aceclidine ophthalmic solution 1.44%] is a defining moment for LENZ and represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States. 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,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.1 “This significant milestone is the result of tremendous commitment and collaboration by the LENZ team and our partners, the dedication of our clinical investigators, and the contributions of hundreds of participants in our clinical trials. I want to thank each of them for their role in getting [aceclidine ophthalmic solution 1.44%] FDA approved.”

References:

1. LENZ Therapeutics. LENZ Therapeutics, Inc. LENZ Therapeutics, Inc. Published July 31, 2025. Accessed July 31, 2025. https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia

2. LENZ Therapeutics. LENZ Therapeutics, Inc. LENZ Therapeutics, Inc. Published April 3, 2024. Accessed July 31, 2025. https://ir.lenz-tx.com/news-events/press-releases/detail/11/lenz-therapeutics-announces-positive-topline-data-from-phase-3-clarity-presbyopia-trials