VIZZ works by contracting the iris sphincter muscle, creating a pinhole effect that extends the depth of focus, thereby improving vision.
LENZ Therapeutics has received the US Food and Drug Administration (FDA) approval for VIZZ (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in adults.
VIZZ is a once-daily eye drop designed to restore clear near vision for up to 10 hours. It is preservative-free and comes in single-dose vials.
The eye drop works by contracting the iris sphincter muscle, creating a pinhole effect that extends the depth of focus, thereby improving vision.
VIZZ is the first aceclidine-based eye drop approved by the FDA for this condition.
LENZ plans to commercialise the eye drops in the US by mid-Q4 2025, with samples anticipated as early as October 2025.
LENZ Therapeutics president and CEO Eef Schimmelpennink said: “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 US.
“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.”
The FDA approval was based on three Phase 3 studies, CLARITY 1, CLARITY 2, and CLARITY 3.
CLARITY 1 and 2 evaluated the safety and efficacy of VIZZ in 466 participants over 42 days, and CLARITY 3 evaluated the long-term safety in 217 participants over six months.
In the Phase 3 programme, VIZZ met all primary and secondary endpoints, demonstrating rapid and sustained near vision improvement.
The eye drops led to no serious treatment-related adverse events in more than 30,000 treatment days across all trials.
The most common adverse reactions include instillation site irritation, dim vision, and headache. Other reactions include conjunctival hyperaemia and ocular hyperaemia, which are mild, transient, and self-resolving.
LENZ Therapeutics plans to initiate direct-to-eye care professional sales and marketing activities in the US, immediately following the FDA approval.
VIZZ clinical investigator Marc Bloomenstein said: “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.”
