LENZ Therapeutics submits MAA for Vizz to UK’s Medicines and Healthcare Products Regulatory Agency

LENZ Therapeutics, Inc. has submitted a marketing authorization application (MAA) to the UK’s Medicines and Healthcare Products Regulatory Agency for Vizz (aceclidine ophthalmic solution) 1.44%, an eye drop for the treatment of presbyopia in adults. The company said the submission marks its sixth regulatory filing outside the US following 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 which now includes a key regulatory advancement for the over 20 million adults in the United Kingdom affected by age-related blurry near vision. Positive early patient and ECP feedback on Vizz has been resounding that our product provides a highly effective, once-daily alternative to reading glasses,” said Eef Schimmelpennink, president and CEO of LENZ Therapeutics, in the release. “On the heels of our recent MAA submission to the European Medicines Agency, our submission to the MHRA is an important step to enable broad commercialization across Europe as we continue to build Vizz into a global brand.”

The application is supported by data from 3 randomized, double-masked, controlled phase 3 CLARITY trials conducted in the US. According to the company, Vizz met all primary and secondary endpoints, demonstrating improvement in near vision within 30 minutes with effects lasting up to 10 hours. The treatment was reported to be well tolerated, with no serious treatment-related adverse events observed across more than 30,000 treatment days.

Presbyopia is an age-related condition that affects near vision, typically becoming noticeable in individuals in their mid-40s. It is commonly managed with reading glasses, prescription lenses, or contact lenses following evaluation by an eye care professional.

Reference:

1. LENZ Therapeutics announces submission of marketing authorization application to the Medicines and Healthcare Products Regulatory Agency for Vizz^® for the treatment of presbyopia in the United Kingdom. News release. LENZ Therapeutics. April 20, 2026. Accessed April 22, 2026. https://ir.lenz-tx.com/news-events/press-releases/detail/53/lenz-therapeutics-announces-submission-of-marketing-authorization-application-to-the-medicines-and-healthcare-products-regulatory-agency-for-vizz-for-the-treatment-of-presbyopia-in-the-united-kingdom