Lenz Therapeutics Inc. announced the US Food and Drug Administration (FDA) approval of Vizz (aceclidine ophthalmic solution) 1.44%, an eye drop for the treatment of presbyopia in adults.

Vizz contracts the iris sphincter muscle resulting in a pinhole effect and achieves a sub-2 mm pupil that extends depth of focus to significantly improve near vision without causing a myopic shift, according to the company.

Safety and efficacy were evaluated in the CLARITY 1, 2, and 3 trials. CLARITY 1 and 2 included 466 participants who were dosed once daily for 42 days, while CLARITY 3 evaluated 217 participants for long-term safety over 6 months with once-daily dosing. 

According to a press release on the approval, Vizz met all primary and secondary near vision improvement endpoints. Improvements were demonstrated within 30 minutes and lasted up to 10 hours. The most common adverse events reported were instillation site irritation, dim vision, and headache, and were mild, transient, and self-resolving.

Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025.