Industry News
FDA Approves First Aceclidine-based Eye Drop for Presbyopia
LENZ Therapeutics has announced that the US Food and Drug Administration (FDA) has approved its aceclidine ophthalmic solution, branded as VIZZ (www.VIZZ.com), for the treatment of presbyopia.
According to the company, the approval makes VIZZ (aceclidine ophthalmic solution 1.44%) the first and only FDA-approved aceclidine-based eye drop. LENZ expects to distribute product samples in the United States from October 2025, with broader commercial availability anticipated by late in the fourth quarter of the year. Direct sales and marketing to eyecare professionals will begin immediately.
“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,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “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.”
VIZZ works by contracting the iris sphincter muscle to create a pinhole effect, extending depth of focus and improving near vision without inducing a myopic shift. Its active ingredient, aceclidine, is new to the US market and marks a global first in presbyopia treatment.
“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,” said VIZZ clinical investigator Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona. “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.”
The FDA’s decision was supported by results from three Phase 3 studies, CLARITY 1, 2 and 3, involving more than 680 participants. VIZZ improved near vision within 30 minutes of dosing, with effects lasting up to 10 hours. No serious treatment-related adverse events were reported during more than 30,000 days of treatment exposure. The most common side effects were mild and temporary, including eye irritation, dim vision and headache.
