Key Takeaways

Lenz Therapeutics announced the submission of a Marketing Authorization Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for Vizz (aceclidine ophthalmic solution) 1.44%, a treatment for presbyopia in adults.

Vizz is the first and only aceclidine-based eye drop designed to address age-related blurry near vision. The submission marks the company’s sixth regulatory filing outside the United States as it works to expand global access to the therapy following its FDA approval in July 2025.

“As we advance in the early product launch in the United States, we continue to position Vizz for broad international expansion,” said Eef Schimmelpennink, President and Chief Executive Officer of Lenz Therapeutics. “Positive early patient and eye care professional feedback has been resounding that our product provides a highly effective, once-daily alternative to reading glasses.”

The UK filing follows MAA submission to the European Medicines Agency last month.

The application is supported by results from three phase 3 clinical trials, known as the CLARITY studies. These randomized, double-masked, controlled trials conducted in the United States met all primary and secondary endpoints. Data showed that Vizz improved near vision within 30 minutes of administration, with effects lasting up to 10 hours. Across more than 30,000 treatment days in the CLARITY trials, Vizz was well tolerated, with no serious treatment-related adverse events reported.