Lotus Pharmaceutical has submitted a new drug application (NDA) to the Ministry of Food and Drug Safety (MFDS) for VIZZ (aceclidine ophthalmic solution) 1.44%, seeking approval in South Korea for presbyopia treatment in adults.
This submission is the initial application for VIZZ under the exclusive licence and commercialisation agreement signed between LENZ Therapeutics and Lotus in May 2025, and includes South Korea along with select Southeast Asian countries.
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The NDA submission is based on findings from three double-masked, randomised, controlled Phase III CLARITY studies carried out in the US.
In the studies, VIZZ met all primary and secondary endpoints for near vision improvement, showed ability to improve near vision within 30 minutes and maintained results for up to 10 hours.
The once-daily eye drop was observed to be generally well-tolerated and no serious adverse events related to the treatment were reported in more than 30,000 treatment days.
Reported adverse reactions included eye redness, dim vision, instillation site irritation and headache. Most adverse reactions were transient, resolved and mild without intervention.
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By GlobalDataUnder the agreement, LENZ could receive up to $125m in milestone payments tied to regulatory and commercial achievements, along with tiered, double-digit royalties based on future net sales.
Beyond South Korea, Lotus has exclusive rights to develop, manufacture, register and commercialise VIZZ for presbyopia across Brunei, Indonesia, Malaysia, the Philippines, Singapore, Thailand and Vietnam.
Lotus CEO Petar Vazharov stated: “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.”
In June 2023, Lotus and Teraju Pharma entered a strategic partnership to market Lotus’ products in a range of therapeutic areas in Malaysia.
