FDA Approves VIZZ Eye Drop for Presbyopia Treatment

Lenz Therapeutics has received U.S. FDA approval for VIZZ (aceclidine ophthalmic solution 1.44%), marking a significant milestone in the treatment of presbyopia. VIZZ is the first and only FDA-approved aceclidine-based eye drop specifically designed to address near vision loss in adults. It is expected to be commercially available in the U.S. by Q4 2025, with product sampling anticipated as early as October 2025.

FDA Approval Expands Treatment Options for Presbyopia

VIZZ introduces a novel, once-daily therapeutic option for the estimated 128 million adults in the U.S. living with blurry near vision due to presbyopia.
“This FDA approval of VIZZ is a defining moment for Lenz and represents a transformative improvement in the available treatment options,” said Eef Schimmelpennink, President and CEO of Lenz Therapeutics.
He added, “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.”

Differentiated Mechanism of Action

VIZZ operates as a predominantly pupil-selective miotic, targeting the iris sphincter muscle with minimal ciliary muscle stimulation. This mechanism induces a pinhole effect by creating a sub-2mm pupil, which increases depth of focus and improves near vision without inducing a myopic shift, a common drawback of other miotic treatments.

The drug’s active ingredient, aceclidine, is a new chemical entity in the U.S. and its approval by the FDA represents a global first for this compound in presbyopia treatment.

Overview of Phase 3 Clinical Trial Results

FDA approval of VIZZ was based on results from three Phase 3 clinical trials. CLARITY 1 and CLARITY 2 were randomized, double-masked, controlled studies that evaluated 466 participants who were dozed once daily over a 42-day period. Both trials successfully met all primary and secondary endpoints, demonstrating that VIZZ improved near vision within 30 minutes of administration, with effects lasting up to 10 hours.

CLARITY 3 was a long-term safety study that included 217 participants over a six-month period of once-daily dosing. This trial confirmed the favorable safety profile of VIZZ, with no serious treatment-related adverse events observed across more than 30,000 treatment days.

VIZZ was well-tolerated, with the most commonly reported side effects being instillation site irritation, dim vision, and headache. These reactions were generally mild, transient, and self-resolving.

Clinical and Market Perspectives

Dr. Marc Bloomenstein, OD, FAAO, a VIZZ clinical investigator at Schwartz Laser Eye Care Center in Scottsdale, Arizona, commented:

“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.”

Commercial Rollout Plans

Lenz Therapeutics plans to begin direct-to-eye care professional sales and marketing immediately. VIZZ samples are expected in October 2025, with full commercial availability by mid-Q4 2025.