Lotus Submits NDA for VIZZ Presbyopia Treatment in South Korea

Lotus Pharmaceutical and LENZ Therapeutics have announced the submission of a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety (MFDS) for the review and potential approval of VIZZ, a once-daily ophthalmic solution for the treatment of presbyopia in adults.

First Regulatory Filing Under LENZ–Lotus Licensing Agreement

This NDA marks the first regulatory submission under the exclusive licensing and commercialization agreement signed between LENZ and Lotus in May 2025. As part of this partnership, LENZ is eligible to receive up to $125 million in regulatory and commercial milestone payments, in addition to tiered, double-digit royalties on future net sales of VIZZ.

The agreement gives Lotus exclusive rights for the development, manufacturing, registration, and commercialization of VIZZ not only in South Korea but also across several Southeast Asian countries, including Thailand, the Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore.

Submission Supported by Positive U.S. CLARITY Trial Data

The NDA in South Korea is backed by robust clinical results from the CLARITY trials conducted in the United States, where VIZZ successfully met all primary and secondary endpoints related to near vision improvement. These data provided the foundation for the therapy’s FDA approval in July 2025, followed by its commercial launch in the U.S. in September 2025.

Executive Commentary

Petar Vazharov, CEO of Lotus Pharmaceutical, emphasized the strategic importance of this milestone:

“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.”

Vazharov further added that the company is well-positioned to enable an efficient market launch with minimal incremental investment, offering a life-changing solution for millions of South Koreans living with presbyopia.

About VIZZ

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop designed to restore clear near vision for up to 10 hours. Its mechanism of action relies on a pupil-selective miotic effect, contracting the iris sphincter muscle with minimal ciliary muscle stimulation. This creates a sub-2 mm pupil that produces a pinhole effect, extending the eye’s depth of focus without inducing a myopic shift.