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

About this update from Lenz Therapeutics, Inc.

MHRA submission follows EMA validation of the VIZZ MAA in March 2026 Sixth ex-U.S. regulatory submission for VIZZ underscores accelerating global expansion SAN DIEGO, April 20, 2026 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) today announced that it has submitted a Marketing Authorization Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) 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. Since receiving U.S. Food and Drug Administration (FDA) approval in July 2025, LENZ has moved rapidly to expand global access to VIZZ, with submission of the MAA in the United Kingdom representing the sixth ex-U.S. regulatory submission for VIZZ. “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 Chief Executive Officer of LENZ Therapeutics. “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 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. About Presbyopia Presbyopia is the inevitable loss of near vision associated with aging, impacting the daily lives of nearly all people over the age of 45. As people age, the crystalline lens in their eyes gradually hardens and becomes less able to change shape. This loss of elasticity of the lens reduces the ability of the lens to focus incoming light from near objects onto ...

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