FDA Approves Vizz Eye Drops to Improve Near Vision in Adults

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By Lori Solomon HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 6, 2025.

via HealthDay

WEDNESDAY, Aug. 6, 2025 -- The U.S. Food and Drug Administration has approved Vizz 1.44 percent (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 <2 mm, which extends depth of focus to significantly improve near vision without causing a myopic shift.

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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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-08-07 06:00

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