LENZ Therapeutics and Lotus Pharmaceutical have reached a key regulatory milestone with the submission of a New Drug Application (NDA) to South Korea’s Ministry of Food and Drug Safety (MFDS) for VIZZ™, a novel treatment for presbyopia in adults. The filing marks the first regulatory submission under the exclusive licensing and commercialization agreement the two companies signed in May 2025, which covers South Korea and several Southeast Asian markets.
Presbyopia, an age-related condition that gradually reduces the eye’s ability to focus on nearby objects, affects millions of adults globally, typically beginning after the age of 40. With increasing demand for non-invasive, drop-based treatments, VIZZ aims to offer a convenient therapeutic alternative to reading glasses in one of Asia’s most rapidly aging populations.
The NDA is supported by data from three pivotal Phase 3 CLARITY trials conducted in the United States. These randomized, double-masked, controlled studies demonstrated that VIZZ met all primary and secondary endpoints related to near-vision improvement. In clinical testing, the therapy showed the ability to improve near vision within 30 minutes of administration and maintain its effect for up to 10 hours—a duration that positions it competitively among emerging presbyopia treatments.
Across more than 30,000 treatment days, the product exhibited a favorable safety profile, with no serious treatment-related adverse events reported. The most common adverse reactions observed included instillation-site irritation, dim vision, headache, and eye redness, with the majority of these effects being mild, short-lived, and self-resolving. The robust efficacy and tolerability data have contributed to rising expectations for VIZZ as it moves through global regulatory pathways.
Under the licensing agreement, LENZ Therapeutics is eligible to receive up to $125 million in combined regulatory and commercial milestone payments, alongside tiered, double-digit royalties on future net sales. Lotus holds exclusive rights to develop, manufacture, register, and commercialize the therapy in South Korea as well as in key Southeast Asian markets including Thailand, the Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore. The broad scope of these rights reflects strategic ambitions from both companies to capitalize on rising demand for presbyopia solutions across the Asia-Pacific region.
Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, described the submission as an important advancement for the company’s expansion strategy. “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 said. He noted that the company is well positioned to execute an efficient launch with minimal additional investment. “Most importantly, VIZZ has the potential to be a truly life-changing option for millions of South Koreans living with presbyopia,” he added.
Eef Schimmelpennink, President and CEO of LENZ Therapeutics, echoed this sentiment, highlighting the strength of the collaboration. “Lotus’ completion of the MFDS filing marks the second submission for VIZZ in Asia, an important step in bringing this therapy to patients worldwide,” he said. Schimmelpennink reaffirmed LENZ’s commitment to expanding global access through partnerships and expressed confidence in Lotus’ capabilities as the drug progresses toward commercial availability.
With regulatory review now underway, both companies anticipate meaningful progress in bringing VIZZ to market in South Korea and, eventually, across Southeast Asia—offering a promising new option for adults seeking improved vision without reliance on corrective eyewear.