US-based LENZ Therapeutics and South Korea's Lotus Pharmaceutical have announced that the latter has submitted a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety (MFDS) for VIZZ, a treatment for presbyopia in adults.
This marks the first approval submission under the companies’ exclusive license and commercialization agreement signed in May 2025 for South Korea and select Southeast Asian countries.
The NDA is supported by robust data from three US-based Phase 3 CLARITY trials, in which VIZZ met all primary and secondary endpoints. Patients experienced near-vision improvement within 30 minutes, lasting up to 10 hours. The therapy was well tolerated, with no serious treatment-related adverse events reported over 30,000 treatment days. Common side effects included mild, transient instillation site irritation, dim vision, headache, and eye redness.
Under the licensing agreement, LENZ is eligible for up to $125 million in regulatory and commercial milestone payments, plus tiered, double-digit royalties on future net sales. Lotus holds exclusive rights to develop, manufacture, register, and commercialize VIZZ in South Korea and parts of Southeast Asia, including Thailand, the Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore.
Petar Vazharov, CEO of Lotus Pharmaceutical, said: "We are proud to have completed the MFDS submission for VIZZ in South Korea, a key milestone that reflects the strength of our partnership with LENZ. South Korea is one of the core markets for Lotus, and this filing supports our strategy to expand our current portfolio by leveraging our established commercial footprint and field force.
"With these capabilities already in place, we 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 we are committed to working closely with regulators to bring it to patients as quickly as possible."
Eef Schimmelpennink, President and CEO of LENZ Therapeutics, added: "LENZ is committed to collaborating with trusted partners like Lotus Pharmaceutical to expand global access to VIZZ. Lotus’ completion of the MFDS filing marks the second submission for VIZZ in Asia, an important step in bringing this therapy to patients worldwide."
"We’re excited to reach this achievement together and look forward to supporting Lotus as they advance toward commercial availability in South Korea across Southeast Asia."
