LENZ Therapeutics Aktie 133904024 / US52635N1037
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02.12.2025 13:56:01
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LENZ Therapeutics' Partner Lotus Pharma Seeks Approval For VIZZ To Treat Presbyopia In South Korea
(RTTNews) - LENZ Therapeutics Inc.'s (LENZ) partner Lotus Pharmaceutical Co., Ltd. (1795.TW,LTUS.PK) has submitted a New Drug Application to the Ministry of Food and Drug Safety seeking approval of VIZZ, for the treatment of presbyopia in adults in South Korea.
VIZZ is a preservative-free, single-use, once-daily eye drop containing aceclidine, a pupil-selective miotic agent. Miotics are a class of drugs that temporarily constrict the pupil to provide increased depth of focus in presbyopes.
The NDA Submission to the Ministry of Food and Drug Safety was backed by positive data from three randomized, double-masked, controlled Phase 3 studies known as CLARITY trials conducted in the United States. In the trials, VIZZ achieved all primary and secondary near vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours.
LENZ Therapeutics is partnered with Lotus Pharma to commercialize VIZZ for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore, under an agreement signed in May of 2025.
The NDA submission in South Korea marks the first official regulatory submission for approval after the exclusive license and commercialization agreement between the two companies.
As per the May 2025 agreement terms, LENZ is entitled to receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales.
Presbyopia is the age-related decline in near vision that occurs as the eye gradually loses its ability to focus on close objects, resulting in blurry near vision.
LENZ Therapeutics' VIZZ was approved in the U.S. for the treatment of presbyopia in adults this July.
LENZ closed Monday's trading at $30.40, down 30.40%.
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| LENZ Therapeutics Inc Registered Shs | 25.04 | -5.12% |
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