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

LENZ
  • Lotus Pharmaceutical submitted a New Drug Application to South Korea's MFDS for VIZZ to treat presbyopia in adults.
  • This filing marks the first approval submission under the exclusive license agreement signed in May 2025 between Lotus & LENZ Therapeutics.
  • Lotus holds exclusive development, manufacturing, registration, & commercialization rights for VIZZ in South Korea & select Southeast Asian nations including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, & Singapore.
  • The NDA relies on positive data from three Phase 3 CLARITY trials where VIZZ achieved all vision improvement endpoints within 30 minutes lasting up to 10 hours.
  • VIZZ demonstrated safety with no serious treatment-related adverse events across over 30,000 treatment days.
  • Common adverse reactions included instillation site irritation (20%), dim vision (16%), headache (13%), conjunctival hyperemia (8%), & ocular hyperemia (7%).
  • LENZ Therapeutics is eligible for up to $125 million in regulatory & commercial milestone payments plus tiered double-digit royalties on future net sales.
  • VIZZ is a preservative-free, once-daily eye drop containing 1.44% aceclidine that uses a pinhole effect to improve near vision.
  • Patients should remove contact lenses before use & wait 10 minutes before reinsertion; driving is advised against if vision is temporarily dim.
  • This MFDS submission is the second VIZZ approval filing in Asia following previous regulatory activities.