Lenz Therapeutics, Inc. has just announced the US Food and Drug Administration's (FDA) approval of Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in adults. Vizz is the first and only aceclidine-based eye drop approved for this purpose and is expected to provide a significant improvement in treatment options for the approximately 128 million adults in the United States affected by blurry near vision.
Vizz is a once-daily solution that has shown proven efficacy for up to 10 hours. The company anticipates samples to be available in the US as early as October 2025, with commercial product availability expected by mid-Q4 2025. This approval marks a significant milestone for Lenz Therapeutics and is poised to be a transformative development in the pharmaceutical market.
Clinical trials for Vizz involved three randomized, double-masked, controlled phase 3 studies, including Clarity 1, Clarity 2, and Clarity 3. These studies evaluated the safety and efficacy of Vizz in a total of 466 participants who were dosed once daily for 42 days. Additionally, Clarity 3 assessed 217 participants for long-term safety over a 6-month duration of once-daily dosing. The results showed that Vizz achieved all primary and secondary near vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. Furthermore, Vizz was well-tolerated, with no serious treatment-related adverse events observed in over 30,000 treatment days across all three Clarity trials.
Eef Schimmelpennink, President and CEO of Lenz Therapeutics, expressed excitement about the FDA approval, emphasizing the commitment and collaboration of the Lenz team and their partners, as well as the contributions of clinical investigators and trial participants.
Vizz is powered by aceclidine, which has a differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris with minimal ciliary muscle stimulation. This unique mechanism results in a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. The FDA approval of Vizz marks a global first in the treatment of presbyopia and represents a disruptive paradigm shift in treatment options for individuals struggling with age-related loss of near vision.
The most common reported adverse reactions of participants in the trials were installation site irritation, dim vision, and headache, with the majority of adverse reactions being mild, transient, and self-resolving.
Lenz Therapeutics plans to initiate direct-to-eye care professional sales and marketing activities immediately and will be hosting a conference call and webcast on August 1, 2025, at 8:00 a.m. EDT.
The approval of Vizz represents a significant advancement in the treatment of presbyopia and is expected to have a major impact on the pharmaceutical market, offering a promising solution for individuals with blurry near vision. Today the company's shares have moved -1.67% to a price of $30.245. For the full picture, make sure to review LENZ Therapeutics's 8-K report.
