Lenz's Vizz Secures FDA Approval for Presbyopia Treatment, Aiming to Disrupt Untapped Market

Lenz Therapeutics has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of Vizz, a novel aceclidine eye drop solution for the treatment of presbyopia. This development marks a potential turning point in addressing the large and underserved market for age-related blurry near vision, affecting millions of adults in the United States.

Vizz: A New Contender in Presbyopia Treatment

Vizz, an aceclidine 1.44% solution, has been cleared by the FDA to treat adults with presbyopia, commonly known as age-related blurry near vision. Lenz Therapeutics plans to make samples available as early as October, with broader commercial supply expected around November.

The drug's novel mechanism of action as a pupil-selective miotic primarily interacts with the iris rather than the ciliary muscle. By contracting the iris sphincter muscle, Vizz produces a sub-2mm pupil that extends the depth of focus, improving near vision without compromising distance vision.

Two phase 3 trials, Clarity 1 and 2, demonstrated Vizz's efficacy, meeting all primary and secondary near vision improvement endpoints. The drug showed the ability to enhance near vision within 30 minutes, with effects lasting up to 10 hours.

Market Potential and Competition

Presbyopia represents a "large, untapped" market, according to analysts at William Blair. While AbbVie's Vuity became the first FDA-approved eye drop for presbyopia in 2021, its commercial performance has been underwhelming, failing to secure a separate line in AbbVie's revenue reports as of 2025's second quarter.

Vizz's differentiated efficacy and durability position it favorably against competitors like Vuity, which has faced challenges with safety issues such as blurred vision and headache, potentially affecting patient adherence. Moreover, Vizz's once-daily administration provides a longer duration of effect compared to Vuity's nine-hour maximum, even after an additional FDA approval for twice-daily dosing.

William Blair analysts believe Vizz holds blockbuster sales potential, citing its best-in-class profile as a key factor that may contribute to a successful market launch.

Safety Considerations and Commercial Preparations

The FDA label for Vizz includes a warning about the risk of retinal tear or detachment, a known risk for all miotics. However, no cases have been observed specifically with Vizz in clinical trials, leading analysts to suggest that this issue is unlikely to significantly impact adoption.

One notable aspect of Vizz's administration is that while labeled as a once-daily solution, it is recommended to be given as two drops per eye, two minutes apart. Analysts consider this a minor distinction in the drug's commercial profile.

To prepare for Vizz's commercialization, Lenz has hired an 88-member sales force, as disclosed in the company's second-quarter report. Lenz CEO Eef Schimmelpennink emphasized the transformative potential of Vizz, stating, "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."