The FDA has approved VIZZ, a once-daily eye drop designed to improve near vision in adults with presbyopia for up to 10 hours. LENZ Therapeutics, Inc. announced the approval of VIZZ (aceclidine ophthalmic solution) 1.44% prescription eye drops.
This indicates a significant advancement in the treatment options available for age-related vision loss. Commercial samples of VIZZ are expected to be available in the United States by October 2025. Full market availability is anticipated by the end of the year.
Presbyopia typically affects individuals over the age of 45. It is caused by the gradual hardening of the eye’s crystalline lens, making it difficult to focus on close objects. VIZZ works by contracting the iris sphincter muscle.
This creates a pinhole effect that improves depth of focus and enhances near vision without causing a myopic shift. The clinical data suggests it maintains efficacy for up to 10 hours with a single drop, achieving a sub-2 mm pupil size. “The FDA approval of VIZZ is a defining moment for LENZ.
Focusing on Vizz eye drop benefits
It 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 CEO of LENZ Therapeutics.
The approval follows results from three phase 3 studies. CLARITY 1 and CLARITY 2 evaluated the safety and efficacy of VIZZ in 466 patients over a 42-day period. CLARITY 3 assessed its long-term safety in 217 patients over six months.
Over 30,000 treatment days were observed, with most adverse reactions being mild and self-resolving. The most common side effects included instillation site irritation (20%), dim vision (16%), and headache (13%). Other noted side effects were conjunctival hyperemia (8%) and ocular hyperemia (7%).
Patients using VIZZ should instill one drop in each eye, waiting 10 minutes before applying a second drop. Contact lenses need to be removed before application but can be reinserted 10 minutes later. Pricing details indicate a cost of $79 per month for 25 doses or $198 for three months for 75 doses, though prices may vary by location.
“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 Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona, who was a clinical investigator in the studies. “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.”
This milestone highlights the dedication and collaboration of the LENZ team, their partners, clinical investigators, and the numerous participants in the clinical trials.
