LENZ Therapeutics announced that Lotus Pharmaceutical Co., Ltd. has filed a New Drug Application (NDA) with the South Korean Ministry of Food and Drug Safety (MFDS) for VIZZ, its aceclidine‑based eye drop for presbyopia, on December 1 2025.
VIZZ received U.S. FDA approval on July 31 2025 after three Phase 3 CLARITY trials in the United States demonstrated rapid onset of near‑vision improvement within 30 minutes and sustained benefit for up to 10 hours, with no serious treatment‑related adverse events reported across more than 30,000 patient treatment days.
The filing marks VIZZ’s first regulatory submission in South Korea and the second in Southeast Asia, following a Thailand submission earlier in 2025. Lotus holds exclusive development, manufacturing, registration and commercialization rights for VIZZ in South Korea and several other Southeast Asian countries, positioning LENZ to unlock up to $125 million in regulatory and commercial milestone payments.
With successful registration, LENZ would gain access to a South Korean market of more than 50 million adults with presbyopia, while also strengthening its foothold in a region where presbyopia treatments are emerging. The partnership with Lotus, combined with the drug’s proven safety and efficacy profile, supports LENZ’s strategy to expand globally and capture a share of the estimated $3 billion‑plus U.S. presbyopia market through international licensing and sales.
CEO Eef Schimmelpennink said the FDA approval “is a defining moment for LENZ and represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States.” He added that the company is “committed to accelerating commercialization in high‑growth markets,” underscoring the strategic importance of the South Korean filing.
The Thailand submission, completed earlier in 2025, and the South Korean filing together illustrate LENZ’s aggressive regulatory strategy in Southeast Asia, a region where presbyopia prevalence is high and competition from other miotic eye drop developers is intensifying.
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