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LENZ Therapeutics' stock surged 12.5% in pre-market trading on August 1, 2025, following the announcement of a significant milestone. The U.S. Food and Drug Administration (FDA) has approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. This approval marks a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States.
VIZZ is a once-daily eye drop designed to restore clear near vision for up to 10 hours. The approval was based on results from three randomized, double-masked, controlled Phase 3 studies, which demonstrated the drug's efficacy and safety. The most common reported adverse reactions were instillation site irritation, dim vision, and headache, with the majority of adverse reactions being mild, transient, and self-resolving.
LENZ Therapeutics is now ready to launch VIZZ into the market, with samples expected in the United States as early as October 2025 and commercial product availability by mid-Q4 2025. The company will host a conference call and webcast on August 1, 2025, at 8:00 a.m. EDT to discuss the approval and its implications for the treatment of presbyopia.
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. The approval of VIZZ is a defining moment for
, highlighting the company's commitment to innovation and collaboration in the development of new treatments for presbyopia.
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