Lenz Therapeutics Files EMA Application for Presbyopia Eye Drop Vizz
Key Takeaways
Lenz Therapeutics has submitted a Marketing Authorization Application to the EMA for Vizz, a potential first-in-class eye drop treatment for presbyopia in adults.
The submission is supported by positive phase 3 CLARITY trial results showing improved near vision within 30 minutes lasting up to 10 hours
Already approved in the United States, Vizz’s EMA filing marks Lenz’s fifth ex-US regulatory submission
Lenz Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for Vizz (aceclidine ophthalmic solution) 1.44%, an investigational eye drop for the treatment of presbyopia in adults.
If approved, Vizz would become the first and only aceclidine-based eye drop available in Europe designed to treat presbyopia. A positive opinion from the EMA would mark a key step toward making the therapy available to millions of Europeans living with the condition.
The EMA submission represents the fifth regulatory filing for Vizz outside the United States. The application is supported by results from three randomized, double-masked, controlled phase 3 clinical studies, collectively known as the CLARITY trials, conducted in the United States.
Across the trials, Vizz met all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes of dosing, with effects lasting up to 10 hours. The therapy also showed a favorable safety profile. Over more than 30,000 treatment days across the studies, Vizz was well tolerated, with no serious treatment-related adverse events reported.
Vizz received approval from the FDA in July 2025 and is currently commercially available in the United States.
Lenz said it plans to pursue commercialization in Europe through strategic partnerships, similar to agreements already established in several regions, including:
Greater China
Republic of Korea and Southeast Asia
Canada
Middle East
“The submission of our Marketing Authorization Application to the EMA is a pivotal milestone for Lenz as we advance our mission to bring Vizz to patients around the world,” said Eef Schimmelpennink, President and Chief Executive Officer of Lenz Therapeutics. “Europe represents a substantial opportunity, with millions of people affected by presbyopia who currently lack a convenient pharmacological treatment option. We believe the strong clinical data from our CLARITY program, combined with the favorable safety and tolerability profile of Vizz, positions us well for a successful regulatory review.”
Originally published on Eyewire.