A new, “first-of-its kind” presbyopia drop will soon be available in the US after the Food and Drug Administration (FDA) approved Lenz Therapeutics’ VIZZ (aceclidine ophthalmic solution) 1.44%.
A media release said it was expected to be broadly available in the fourth quarter of 2025 and was the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.
“We believe yesterday’s approval will establish a new standard-of-care in presbyopia,” said Mr Eef Schimmelpennink, president and CEO of Lenz Therapeutics.
“As we have shown, this is not only best-in-class, but frankly, the only in a class of pupil selective ciliary-sparing myotics.
“This is uniquely engineered, highly-differentiated and designed to deliver quick onset and lasting benefit for the vast majority of presbyopes.”
VIZZ is not the first presbyopia eye drop to be approved by the FDA.
In October 2021, it cleared Vuity (pilocarpine HCl ophthalmic solution) 1.25%, a daily prescription eye drop produced by Allergan, a subsidiary of AbbVie.
The eye drop adopts pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions.
According to Lenz, VIZZ has a 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 and its FDA approval marks a global first in the treatment of presbyopia.
Schimmelpennink said VIZZ was the first and only once-daily eye drop into the market with proven efficacy for up to 10 hours.
The FDA approval of VIZZ was based upon results from three randomised, 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 six-month duration of once daily dosing.
The company said that 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.
The most common reported adverse reactions of participants were installation site irritation, dim vision and headache. The majority of adverse reactions were mild, transient and self-resolving.
“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 Mr 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.”
Samples are anticipated in the US as early as October 2025, with commercial product to be broadly available by mid-Q4 2025.
