Lenz Therapeutics announces MFDS submission of NDA for LNZ100

LENZ Therapeutics (LENZ) and Lotus Pharmaceutical announced that Lotus has submitted a New Drug Application to the Ministry of Food and Drug Safety for the review and approval of VIZZ, 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 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 over 30,000 treatment days across all three CLARITY trials. The most common reported adverse reactions of participants were instillation site irritation, dim vision, headache, and eye redness. The majority of adverse reactions were mild, transient and self-resolving. Under the terms of the licensing and commercialization agreement, LENZ is eligible to receive up to $125 million in regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. In addition to South Korea, Lotus has exclusive development, manufacturing, registration and commercialization rights for VIZZ for the treatment of presbyopia in certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore.