LENZ Therapeutics has announced FDA approval of VIZZ (aceclidine ophthalmic solution) 1.44%, making it "the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults."
The FDA approval was based upon results from three randomized, double-masked, controlled Phase 3 studies. CLARITY 1 and CLARITY 2 were designed to evaluate the safety and efficacy of VIZZ in 466 participants dosed once daily for 42 days. CLARITY 3 evaluated 217 participants for long-term safety over a 6-month duration of once daily dosing. In both CLARITY 1 and CLARITY 2, 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. Near vision improvement was reproducible and consistent across both CLARITY 1 and 2. VIZZ was well-tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days across all three CLARITY trials.
VIZZ is powered by aceclidine, highlighted by its differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity in the US.
“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,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.
VIZZ clinical investigator Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona, added: “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.”
Samples are anticipated in the US by the end of October 2025, with commercial product to be broadly available by mid-Q4 2025.
The FDA approval was based upon results from three randomized, double-masked, controlled Phase 3 studies. CLARITY 1 and CLARITY 2 were designed to evaluate the safety and efficacy of VIZZ in 466 participants dosed once daily for 42 days. CLARITY 3 evaluated 217 participants for long-term safety over a 6-month duration of once daily dosing. In both CLARITY 1 and CLARITY 2, 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. Near vision improvement was reproducible and consistent across both CLARITY 1 and 2. VIZZ was well-tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days across all three CLARITY trials.
VIZZ is powered by aceclidine, highlighted by its differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris, with minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle resulting in a pinhole effect and uniquely achieves a sub-2mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift. Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity in the US.
“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,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.
VIZZ clinical investigator Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona, added: “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.”
Samples are anticipated in the US by the end of October 2025, with commercial product to be broadly available by mid-Q4 2025.
