Lotus Pharma Submits First Regulatory Application for VIZZ Presbyopia Treatment in South Korea
Key Insights
Lotus Pharmaceutical has submitted a New Drug Application to South Korea's Ministry of Food and Drug Safety for VIZZ (search), marking the first regulatory submission under its partnership with LENZ Therapeutics (search).
The application is supported by positive Phase III CLARITY trial data showing VIZZ (search) improved near vision within 30 minutes and maintained effects for up to 10 hours in presbyopia (search) patients.
LENZ Therapeutics (search) stands to receive up to $125 million in milestone payments and double-digit royalties from the partnership covering South Korea and Southeast Asian markets.
Lotus Pharmaceutical Co., Ltd. has submitted a New Drug Application (NDA) to South Korea's Ministry of Food and Drug Safety seeking approval for VIZZ (search), a novel presbyopia (search) treatment developed by partner LENZ Therapeutics (search) Inc. This submission represents the first official regulatory filing under the exclusive licensing and commercialization agreement between the two companies signed in May 2025.
Clinical Evidence Supporting Approval
The NDA submission is backed by robust clinical data from three randomized, double-masked, controlled Phase III studies known as the CLARITY trials, conducted in the United States. In these pivotal studies, VIZZ (search) achieved all primary and secondary near vision improvement endpoints, demonstrating the ability to improve near vision within 30 minutes with effects lasting up to 10 hours.
The once-daily eye drop was generally well-tolerated across more than 30,000 treatment days, with no serious adverse events related to the treatment reported. The most commonly reported adverse reactions included eye redness, dim vision, instillation site irritation, and headache. Most adverse reactions were described as transient, mild, and resolved without intervention.
Novel Mechanism of Action
VIZZ (search) is formulated as a preservative-free, single-use, once-daily eye drop containing aceclidine, a pupil-selective miotic agent. Miotics represent a class of drugs that temporarily constrict the pupil to provide increased depth of focus in presbyopes, addressing the age-related decline in near vision that occurs as the eye gradually loses its ability to focus on close objects.
Strategic Partnership and Market Expansion
The partnership agreement between LENZ Therapeutics (search) and Lotus Pharma encompasses commercialization rights for VIZZ (search) in South Korea and several Southeast Asian countries, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore. Under the agreement terms, LENZ is entitled to receive up to $125 million in upfront, regulatory, and commercial milestone payments, as well as tiered, double-digit royalties on future net sales.
Lotus CEO Petar Vazharov emphasized the strategic importance of this submission, stating, "We are proud to have completed the MFDS submission for VIZZ (search) 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."
Market Opportunity and Patient Impact
Vazharov highlighted the potential patient impact, noting that "VIZZ (search) has the potential to be a truly life-changing option for millions of South Koreans living with presbyopia (search)." The company expressed commitment to working closely with regulators to bring the treatment to patients as quickly as possible.
VIZZ (search) received approval in the United States for the treatment of presbyopia (search) in adults in July, providing a regulatory precedent for the South Korean submission. The treatment addresses a significant unmet medical need in presbyopia, a condition that affects the ability to focus on close objects due to age-related changes in the eye.