LENZ Therapeutics and Lotus Pharmaceutical Submit VIZZ for Presbyopia Treatment Approval in South Korea
核心洞察
Lotus Pharmaceutical has submitted a New Drug Application to South Korea's Ministry of Food and Drug Safety for VIZZ (搜索), marking the second regulatory submission for the presbyopia (搜索) treatment in Asia.
The submission is supported by positive Phase 3 CLARITY trial data showing VIZZ (搜索) achieved all primary and secondary endpoints, improving near vision within 30 minutes for up to 10 hours.
Under the licensing agreement, LENZ is eligible for up to $125 million in milestone payments and double-digit royalties, while Lotus gains exclusive rights across South Korea and Southeast Asia.
Lotus Pharmaceutical Co., Ltd. has submitted a New Drug Application (NDA) to South Korea's Ministry of Food and Drug Safety (MFDS) for VIZZ (搜索) (aceclidine ophthalmic solution) 1.44%, seeking approval for the treatment of presbyopia (搜索) in adults. This marks the first regulatory submission under the exclusive licensing and commercialization agreement signed between Lotus and LENZ Therapeutics (搜索) in May 2025, representing the second submission for VIZZ in Asia.
Clinical Evidence Supporting Approval
The NDA submission is backed by robust clinical data from three randomized, double-masked, controlled Phase 3 studies known as the CLARITY trials, conducted in the United States. VIZZ (搜索) achieved all primary and secondary near vision improvement endpoints in these studies, demonstrating the ability to improve near vision within 30 minutes with effects lasting up to 10 hours.
The safety profile across the CLARITY trials was favorable, with no serious treatment-related adverse events observed over 30,000 treatment days. The most common reported adverse reactions included instillation site irritation (20%), dim vision (16%), and headache (13%). Additional adverse reactions reported in more than 5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were characterized as mild, transient, and self-resolving.
Commercial Partnership and Financial Terms
Under the licensing and commercialization agreement, LENZ Therapeutics (搜索) is eligible to receive up to $125 million in regulatory and commercial milestone payments, along with tiered, double-digit royalties on future net sales. Lotus has secured exclusive development, manufacturing, registration, and commercialization rights for VIZZ (搜索) in South Korea and several Southeast Asian countries, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore.
"We are proud to have completed the MFDS submission for VIZZ (搜索) in South Korea, a key milestone that reflects the strength of our partnership with LENZ," said Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical. "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."
Mechanism of Action and Drug Profile
VIZZ (搜索) is a once-daily eye drop that functions as a predominantly pupil selective miotic, interacting with the iris while providing minimal ciliary muscle stimulation. The drug causes contraction of the iris sphincter muscle (搜索), creating a pinhole effect that extends depth of focus to improve vision. Aceclidine serves as the sole active ingredient, providing rapid and durable near vision improvement. The formulation is preservative-free and supplied in single-dose vials.
Addressing Unmet Medical Need
Presbyopia (搜索) represents an inevitable loss of near vision associated with aging, impacting the daily lives of nearly all people over the age of 45. As individuals age, the crystalline lens gradually hardens and becomes less able to change shape, reducing the lens's ability to focus incoming light from near objects onto the retina. Adults over 50 years of age lose, on average, 1.5 lines of near vision every six years.
The condition affects an estimated 1.8 billion people globally and 128 million people in the United States. While presbyopia (搜索) progression is gradual, patients often experience an abrupt change in daily life as symptoms become more pronounced in their mid-40s, when reading glasses or other corrective aids suddenly become necessary for reading text or conducting close-up work.
"LENZ is committed to collaborating with trusted partners like Lotus Pharmaceutical to expand global access to VIZZ (搜索)," said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics (搜索). "Lotus' completion of the MFDS filing marks the second submission for VIZZ in Asia, an important step in bringing this therapy to patients worldwide."
VIZZ (搜索) represents the first and only FDA-approved aceclidine-based eye drop for presbyopia (搜索) treatment, positioning it as a novel therapeutic option in a market traditionally managed through over-the-counter reading glasses or prescription corrective lenses.