Lotus submits NDA in South Korea for LENZ’s presbyopia treatment VIZZ

LENZ Therapeutics and Lotus Pharmaceutical announced Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZ for the treatment of presbyopia in adults in South Korea.¹

This is the first submission for approval under the exclusive license and commercialization agreement for South Korea that was signed between LENZ and Lotus in May 2025.²

Under the terms of the licensing and commercialization agreement, LENZ is eligible to receive up to $125 million in regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. In addition to South Korea, Lotus has exclusive development, manufacturing, registration, and commercialization rights for VIZZ for the treatment of presbyopia in certain countries in Southeast Asia, including Thailand, the Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore.²

According to the companies, the NDA submission was supported by positive data from the CLARITY trials conducted in the US, in which VIZZ achieved all primary and secondary near vision improvement endpoints.

Petar Vazharov, CEO of Lotus Pharmaceutical, commented on the submission, saying, “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,” concluded Vazharov.

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours and was approved by the FDA in July 2025.³ It became commercially available in the US at the end of September 2025.⁴

VIZZ’s mechanism of action lies in its predominantly pupil-selective miotic that works with the iris by minimal ciliary muscle stimulation. The drop contracts the iris sphincter muscle, which creates a pinhole effect with a sub-2 mm pupil. This then extends the depth of focus achieved by the eye to improve near vision without causing a myopic shift, the company stated.

References:

1. LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia. Published December 1, 2025. Accessed December 1, 2025. https://ir.lenz-tx.com/news-events/press-releases/detail/45/lenz-therapeutics-announces-mfds-submission-of-new-drug-application-for-lnz100-vizz-in-south-korea-for-the-treatment-of-presbyopia

2. Harp MD. LENZ Therapeutics and Laboratoires Théa partner to commercialize LNZ100 for presbyopia in Canada. Published July 8, 2025. Accessed December 1, 2025. https://www.ophthalmologytimes.com/view/lenz-therapeutics-and-laboratoires-th-a-partner-to-commercialize-lnz100-for-presbyopia-in-canada

3. Kaiser Maharjan E. FDA approves Lenz Therapeutics’ VIZZ for the treatment of presbyopia. Published July 31, 2025. Accessed December 1, 2025. https://www.ophthalmologytimes.com/view/fda-approves-lenz-therapeutics-vizz-for-the-treatment-of-presbyopia

4. Joy J. Vizz officially launches in the United States. Published October 2, 2025. Accessed December 1, 2025. https://www.ophthalmologytimes.com/view/vizz-officially-launches-in-the-united-states