August 15, 2025
Presbyopia is defined as age-related loss of near vision that affects nearly everyone over age 45.
The FDA has approved Vizz, an aceclidine ophthalmic solution 1.44%, making it the first and only aceclidine-based eye drop cleared to treat presbyopia in adults, according to Lenz Therapeutics.
Unlike traditional treatments, Vizz works primarily on the pupil rather than the eye’s ciliary muscle. By contracting the iris’s sphincter muscle, the drop creates a pinhole effect that narrows the pupil to under 2 millimeters, extending the depth of focus and improving near vision without inducing a myopic shift.
Presbyopia is the gradual, age-related loss of near vision that affects nearly everyone over the age of 45. As the eye’s crystalline lens stiffens with age, it becomes less able to focus on close objects. Although the decline is progressive, many patients notice sudden difficulties in daily activities by their mid-40s, prompting the use of over-the-counter reading glasses or prescription corrective lenses.
“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, clinical investigator at 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.”
Approval was supported by results from three phase 3 randomized, double-masked, controlled trials, including CLARITY 1 and CLARITY 2, which met all near vision improvement endpoints. Among 466 participants treated once daily for 42 days, Vizz improved near vision within 30 minutes and lasted up to 10 hours. Data from April 2024 showed that 71% of participants achieved at least a three-line improvement at both 30 minutes and three hours, while 40% maintained that improvement at 10 hours.
Across more than 30,000 treatment days in all three trials, Vizz was well tolerated, with no serious treatment-related adverse events reported. The most common side effects were mild and temporary, including instillation site irritation, dim vision, and headaches.
“The FDA approval of Vizz 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 CEO of LENZ Therapeutics.
RELATED CONTENT: Alcon Laboratories Recalls Systane Eye Drops Nationwide Over Fungal Contamination Risk
