LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia

Core Insights - Lotus Pharmaceutical has submitted a New Drug Application (NDA) for VIZZ in South Korea, marking the second regulatory submission for the drug outside the U.S. [1] - The NDA submission is backed by positive results from three Phase 3 studies in the U.S., demonstrating VIZZ's effectiveness in improving near vision [2] - Under the licensing agreement, LENZ Therapeutics stands to receive up to $125 million in milestone payments and royalties from future sales of VIZZ [3] Company Overview - LENZ Therapeutics is focused on the commercialization of VIZZ, the first FDA-approved aceclidine-based eye drop for presbyopia, which affects approximately 1.8 billion people globally [10] - Lotus Pharmaceutical, founded in 1966, is an international pharmaceutical company with a strong R&D and manufacturing platform, certified by major regulatory authorities [11] Product Information - VIZZ (aceclidine ophthalmic solution) 1.44% is designed to restore clear near vision for up to 10 hours and is preservative-free [6] - The drug is indicated for the treatment of age-related blurry near vision (presbyopia) in adults [7] Market Context - Presbyopia affects nearly all individuals over the age of 45, with significant implications for daily activities and quality of life [5] - The NDA submission in South Korea is part of a broader strategy to expand VIZZ's market presence in Southeast Asia, including countries like Thailand, Vietnam, and Malaysia [3]