FDA Approves of VIZZ Eye Drops to Treat Presbyopia

The FDA has approved VIZZ eye drops (LENZ Therapeutics, Inc.) for the treatment of presbyopia, the gradual loss of near vision associated with aging that affects nearly 130 million American adults.

The active ingredient in VIZZ 1.44% drops is aceclidine, an FDA approved product that contracts the sphincter of the iris, resulting in a pinhole effect that extends depth of focus to improve near vision without causing a myopic shift, according to the drug’s manufacturer.

The FDA decision “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 CEO of the company, in a statement.

The FDA approval followed the results of three randomized controlled phase 3 studies that evaluated the safety and efficacy of VIZZ. CLARITY 1 and CLARITY 2 enrolled 466 participants who received a single daily dose for 42 days; CLARITY 3 included 217 people for a long-term safety analysis over a 6-month period, during which participants took a single daily dose of the eye drops.

VIZZ was associated with improvements in near vision within 30 minutes, and the effects lasted up to 10 hours, according to the company. The product was not linked to serious adverse events related to treatment. Common complaints among participants in the studies were instillation site irritation (20%), dim vision (16%), and headache (13%). Some participants also reported conjunctival hyperemia (8%) and ocular hyperemia (7%), LENZ said. 

“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, of the Schwartz Laser Eye Care Center in Scottsdale, Arizona, who helped conduct the research. “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.”