LENZ News & Events

Reports Q4 revenue $1.59M, consensus $3.09M. "We are encouraged by the early performance of VIZZ. We undoubtedly have a product that works, with broad prescriber uptake and early signs of encouraging refill dynamics reinforcing its best-in-class profile," said Eef Schimmelpennink, president and CEO of Lenz Therapeutics. "We are clearly establishing a new category, with physicians building new habits of identifying appropriate patients and incorporating VIZZ into routine discussions. To accelerate this, we are leaning in by expanding our sales force, driving focused field execution and sharpening our physician messaging, as well as activating targeted consumer campaigns to establish VIZZ as a compelling alternative to reading glasses that is effective for the majority of presbyopes."

LENZ Therapeutics announced that it has submitted a Marketing Authorization Application, MAA, to the European Medicines Agency, EMA, for the review and approval of VIZZ 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 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.