Lotus Pharmaceutical has submitted a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety (MFDS) for VIZZ (aceclidine ophthalmic solution) 1.44%, a treatment for presbyopia (age-related difficulty seeing up close).
This submission is part of an agreement between Lotus and LENZ Therapeutics made in May 2025, which gives Lotus the rights to develop and sell VIZZ in South Korea and several Southeast Asian countries.
The application is based on results from three Phase III studies conducted in the U.S.. These studies showed that VIZZ improved near vision quickly (within 30 minutes) and lasted for up to 10 hours. It was also well-tolerated, with very few side effects, such as eye redness or headache, which were mild and went away without treatment.
Under the agreement, LENZ could receive up to USD 125 million in milestone payments and royalties based on future sales. Lotus also has the rights to sell VIZZ in Brunei, Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.
Executive Statement
According to Lotus CEO Petar Vazharov, they are proud to have completed the MFDS submission for VIZZ in South Korea, a key milestone that reflects the strength of their partnership with LENZ. South Korea is one of the core markets for Lotus, and this filing supports our strategy to expand their current portfolio by leveraging our established commercial footprint and field force. With these capabilities already in place, they can enable an efficient launch that opens new growth avenues with minimal incremental investment. Most importantly, VIZZ has the potential to be a truly life-changing option for millions of South Koreans living with presbyopia, and they are committed to working closely with regulators to bring it to patients as quickly as possible.