FDA has approved VIZZ, a once-daily eye drop developed by LENZ Therapeutics, as a new treatment for presbyopia, an age-related eye condition that makes it difficult to see things up close. This condition affects millions of adults, usually over the age of 45, and often requires reading glasses or contact lenses.
Presbyopia is a natural part of ageing. It happens when the eye’s lens loses flexibility, making it harder to focus on nearby objects. For many people, this means struggling to read a text message, see a menu in a dimly lit restaurant, or check small print on labels.
Until now, most solutions have been glasses, contact lenses, or surgical procedures. With VIZZ’s approval, there is now a new non-surgical option that can improve near vision without affecting distance vision.
VIZZ is the first FDA-approved aceclidine-based eye drop for this purpose. It works by gently tightening the iris, the colored part of the eye, to create what experts call a “pinhole effect.” This effect sharpens near vision, much like narrowing a camera lens brings objects into focus, but without causing blurriness in distance vision.
“This FDA approval 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,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.
“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.”
Clinical studies have shown that VIZZ starts working within 30 minutes and can last for up to 10 hours. The drops were tested in three large Phase II clinical trials, with hundreds of participants and more than 30,000 treatment days. According to the company, the treatment was well tolerated, with no serious side effects reported. Some participants experienced mild, temporary issues, such as slight eye irritation, dim vision, or a headache.
“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 VIZZ clinical investigator Marc Bloomenstein from Schwartz Laser Eye Care Center in Scottsdale, Arizona.
“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.”
In 2021, the first eye drops for presbyopia were introduced under the brand name Vuity. While Vuity was praised for its results, it works differently from VIZZ and can cause side effects such as brow heaviness or rare complications due to its action on the eye’s focusing muscles.
VIZZ uses aceclidine, a pupil-selective miotic, which improves near vision without over-stimulating the focusing muscles. This means it avoids some of the discomforts linked to older treatments.
“This is uniquely engineered, highly differentiated, and designed to deliver quick onset and lasting benefit for the vast majority of presbyopes,” Schimmelpennink explained. “As we have shown, this is not only best-in-class, but frankly, the only in a class of pupil-selective ciliary-sparing myotics.”
Presbyopia develops slowly, but its impact can be sudden for many people. Reading a message or checking instructions can go from being effortless to frustrating overnight. The condition is nearly unavoidable after age 45 and continues to worsen over time. VIZZ offers a daily-use solution that could help people continue their everyday activities from working on a computer to enjoying a good book — without constantly reaching for glasses.
LENZ Therapeutics plans to release free samples of VIZZ in October 2025, with a full market launch expected by the end of the year. Once available, it will be the only FDA-approved aceclidine-based treatment for presbyopia. The company says peer-reviewed publications of its trial results will follow soon, as is common in the medical field. The FDA data and guidance are published here.
