LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia
LENZ Therapeutics, Inc. (LENZ)
Company Research
Source: GlobeNewswire
SAN DIEGO and TAIPEI, Taiwan, Dec. 01, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Lotus Pharmaceutical Co., Ltd. (“Lotus”, TWSW Stock Code: 1795) today announced that Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZTM, for the treatment of presbyopia in adults in South Korea. This represents the first submission for approval under the exclusive license and commercialization agreement signed in May 2025 for South Korea and certain countries in Southeast Asia. The NDA submission was 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 near vision improvement 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
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LENZ
Earnings
- 11/5/25 - Beat
LENZ
Sec Filings
- 11/19/25 - Form 4
- 11/17/25 - Form 144
- 11/14/25 - Form SCHEDULE
- LENZ's page on the SEC website