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LENZ Therapeutics celebrates FDA approval of Vizz, the first aceclidine eye drop for presbyopia.
Vizz becomes the first FDA approved aceclidine-based eye drop treatment for Presbyopia in adults.
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LENZ Therapeutics announced that FDA approved Presbyopia treatment Vizz making it the first and only aceclidine-based eye drop to be granted approval by the FDA, with samples estimated to reach the U.S. in October this year and for the full product to be available by the middle of Q4 2025.
Vizz is mainly comprised of aceclidine with the focal point of its action serving as a pupil-selective miotic that interacts with the iris using minimal ciliary muscle stimulation. Specifically, Vizz contracts the iris sphincter muscle, creating a pinhole effect measuring sub-2mm for pupils. This creates an extended depth of focus directly improving near vison without causing a myopic shift.The lone active ingredient within Vizz is aceclidine, a new chemical entity within the U.S. and its inclusion in Vizz marks the first official global approval of the chemical as a presbyopia treatment option.
Eef Schimmelpennink, president and chief executive officer of LENZ Therapeutics, noted the importance of Vizz’s approval by the FDA, saying, “The FDA approval of Vizz is a defining moment for LENZ and represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States. We are ready and excited to launch the first and only once-daily eye drop with proven efficacy for up to 10 hours into the market. This significant milestone is the result of tremendous commitment and collaboration by the LENZ team and our partners, the dedication of our clinical investigators, and the contributions of hundreds of participants in our clinical trials. I want to thank each of them for their role in getting Vizz FDA approved.”1
FDA granted approval to Vizz due to the results of three randomized double-masked controlled Phase III studies (CLARITY 1, CLARITY 2, and CLARITY 3). Both CLARITY 1 and CLARITY 2 were designed to examine Vizz’s safety and efficiency amongst 466 participants. In the two studies all participants were administered a single dose each day over the span of 42 days, and the end results reviled that CLARITY 1 and CLARITY 2 both achieved primary and secondary near vison improvement endpoints. This demonstrated Vizz’s ability to improve near sighted vison within 30 minutes of dosage, with an active timeframe upwards of 10 hours.
CLARITY 1 and CLARITY 2 also showed that near-vison improvement was reproducible and consistent across both testing fields along with providing proof that Vizz was tolerated amongst participants with no severe adverse events being observed during the 30,000 treatment days across all three CLARITY trials. The most reported reactions of Vizz treatments were instillation sit irritation, headaches, and dim vision.
Vizz clinical investigator Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona, discussed the implications of the approval, saying, “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. 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.”1
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