HQ Team
August 11, 2025: The US Food and Drug Administration (FDA) has granted approval to VIZZ (aceclidine ophthalmic solution 1.44%), an innovative eye drop developed by LENZ Therapeutics, marking the first aceclidine-based treatment for presbyopia to receive FDA approval. This breakthrough offers adults with presbyopia a new option to reduce their reliance on bifocals or reading glasses.
Presbyopia: common age-related vision problem
Presbyopia, a common condition affecting approximately 128 million adults in the US, is characterized by the loss of near vision due to the natural aging process. It typically begins in the mid-40s and progresses, making it difficult to focus on close objects like books or smartphones. Traditional solutions include reading glasses, bifocals, or multifocal contact lenses, but now VIZZ offers a non-invasive alternative.
VIZZ is the first and only once-daily eye drop that utilizes aceclidine, a new chemical entity in the US. It works by gently narrowing the pupil, creating a pinhole effect that extends the depth of focus. This allows for improved near vision without causing a myopic shift or significantly affecting distance vision. The mechanism involves minimal ciliary muscle stimulation, setting it apart from other treatments like Vuity.
Efficacy and safety
The FDA’s approval was based on results from three randomized, double-masked, controlled Phase III trials (CLARITY 1, CLARITY 2, and CLARITY 3). In these trials, the safety and efficacy of Vizz were evaluated in 466 participants who were dosed once per day for a 42-day duration. Vizz demonstrated its ability to improve near vision within 30 minutes and last up to 10 hours. Specifically, an April 2024 news release states that 71% of trial participants achieved 3-line or greater improvement at 30 minutes and 3 hours, and 40% continued to have these improvements at 10 hours.
Of note, Vizz was well tolerated, with no serious treatment-related adverse events (AEs) observed over the 30,000 treatment days across all 3 CLARITY trials.
These trials demonstrated that VIZZ improved near vision within 30 minutes and provided benefits lasting up to 10 hours. No serious treatment-related adverse events were observed across over 30,000 treatment days. Common mild side effects included installation site irritation, dim vision, and headache, which were transient and self-resolving.VIZZ is expected to be available in the US starting in October 2025, with a broader commercial rollout planned for mid-Q4 2025. LENZ Therapeutics will initiate direct-to-eye care professional sales and marketing activities immediately.
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