The U.S. Food and Drug Administration has approved Vizz 1.44% (aceclidine ophthalmic solution) for the treatment of presbyopia in adults.
Vizz is the first and only aceclidine-based eye drop to improve near vision in adults with presbyopia. Vizz contracts the iris sphincter muscle resulting in a pinhole effect, achieving a pupil
The approval was based on data from phase 3 studies: CLARITY 1 and CLARITY 2 evaluated the safety and efficacy of Vizz in 466 participants dosed once daily for 42 days, while CLARITY 3 evaluated 217 participants for long-term safety over six months of once-daily dosing.
Across trials, Vizz demonstrated improved near vision within 30 minutes that lasted up to 10 hours. There were no serious treatment-related adverse events observed across all three trials (30,000 treatment days). The most common reported adverse reactions (mostly mild, transient, and self-resolving) included installation site irritation, dim vision, and 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,” Vizz clinical investigator Marc Bloomenstein, O.D., from the Schwartz Laser Eye Care Center in Scottsdale, Arizona, said in a statement.
“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 Vizz was granted to LENZ Therapeutics.
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FDA approves Vizz eye drops to improve near vision in adults ( 5)
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