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Vizz Approved by FDA for Presbyopia Treatment: First Aceclidine Drops with Rapid Effects of Up to 10 Hours
Last reviewed: 09.08.2025
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The U.S. Food and Drug Administration (FDA) has approved Vizz 1.44% (aceclidine ophthalmic solution) for the treatment of presbyopia in adults.
Vizz is the first and only aceclidine-based eye drops for improving near vision in adults with presbyopia. Vizz contracts the iris sphincter muscle, causing a “pinhole” effect, reaching a pupil <2 mm, which extends the depth of focus and significantly improves near vision without causing 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 with once-daily dosing for 42 days, while CLARITY 3 evaluated 217 participants for long-term safety over six months of once-daily dosing.
In all trials, Vizz demonstrated improvement in near vision within 30 minutes, which was maintained for up to 10 hours. No treatment-related serious adverse events were observed in all three studies (30,000 treatment days). The most commonly reported adverse reactions (mostly mild, transient, and self-limited) were instillation site irritation, blurred vision, and headache.
“This FDA approval represents a breakthrough paradigm shift in treatment options for millions of people who are frustrated and struggling with the inevitable loss of near vision that comes with age,” Vizz clinical researcher Marc Bloomenstein, OD, of Schwartz Laser Eye Care in Scottsdale, Ariz., said in a press release.
“I believe this will be a welcome solution for both optometrists and ophthalmologists, who will now be able to offer a highly effective and in-demand presbyopia treatment that can immediately become standard of care, with a product profile that will meet the needs of our patients.”
Vizz approval was granted to LENZ Therapeutics.