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LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia
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LENZ Therapeutics has received FDA approval for VIZZ (aceclidine ophthalmic solution) 1.44%, making it the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia. This common condition, which affects an estimated 128 million adults in the United States, is an age-related loss of near vision that often requires corrective aids like reading glasses. VIZZ offers a once-daily, preservative-free solution that works through a unique, predominantly pupil-selective miotic mechanism. Its active ingredient, aceclidine, is a new chemical entity in the U.S. that contracts the iris sphincter muscle to create a "pinhole effect," which extends the eye's depth of focus and significantly improves near vision for up to 10 hours. The FDA approval was based on the positive results from three Phase 3 studies (CLARITY 1, 2, and 3), which demonstrated that VIZZ was well-tolerated and consistently achieved near vision improvement within 30 minutes. With product samples expected as early as October 2025 and broad commercial availability by mid-Q4 2025, VIZZ is positioned to be a transformative new option for patients and could potentially become a new standard of care.