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LENZ Therapeutics Announces Submission of Marketing Authorization Application to European Medicines Agency for VIZZ® for the Treatment of Presbyopia
MAA submission to the European Medicines Agency represents a key regulatory milestone in LENZ’s strategy to expand global access to VIZZ Submission of MAA in
About this update from Lenz Therapeutics, Inc.
[{"type":"text","content":"MAA submission to the European Medicines Agency represents a key regulatory milestone in LENZ’s strategy to expand global access to VIZZ Submission of MAA in Europe results in the fifth ex-U.S. regulatory submission for VIZZ SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review and approval of VIZZ® (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for the treatment of presbyopia in adults. If approved, the EMA's positive opinion would serve as a foundational step toward making VIZZ available to the millions of Europeans living with age-related blurry near vision. The submission of the MAA in Europe represents the fifth ex-U.S. regulatory submission for VIZZ. The MAA submission is supported by positive data from three randomized, double-masked, controlled Phase 3 studies (CLARITY trials) conducted in the United States, in which VIZZ achieved all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. VIZZ was well tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all three CLARITY trials. VIZZ was approved by the U.S. Food and Drug Administration (FDA) in July 2025 and is commercially available in the United States. The EMA submission marks the fifth ex-US submission and represents a significant milestone in LENZ’s international expansion strategy to establish VIZZ as a global brand. Presbyopia affects an estimated 1.8 billion people globally, and Europe represents one of the largest markets for vision correction products. LENZ intends to pursue commercialization in Europe through strategic partnerships, complementing partnerships already in place for Greater China, the Republic of Korea and Southeast Asia, Canada, and the Middle East region, and expects to provide further updates as the regulatory review progresses. “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 oppor...