LENZ Therapeutics and Lotus Pharmaceutical Submit New Drug Application
In a significant advance for vision care, LENZ Therapeutics, Inc. (NASDAQ: LENZ) and Lotus Pharmaceutical Co., Ltd. recently announced the submission of a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) in South Korea. This marks a pivotal step for VIZZ™ (aceclidine ophthalmic solution) in addressing presbyopia, a common age-related vision issue. The NDA submission follows a successful partnership agreement in May 2025 that allows Lotus to commercialize VIZZ in South Korea and select Southeast Asian markets.
Positive Clinical Trial Results Bolster NDA Submission
The NDA is backed by promising results from three controlled Phase 3 studies, known as the CLARITY trials, conducted in the United States. VIZZ demonstrated impressive outcomes, achieving all primary and secondary endpoints for improving near vision. The therapy was able to enhance near vision within 30 minutes, with effects lasting up to 10 hours. Significantly, over 30,000 treatment days across the trials showed that VIZZ had a safety profile characterized by mild and temporary adverse reactions, namely site irritation and dim vision.
Commercial Opportunities and Global Reach
Through the partnership agreement with Lotus, LENZ stands to gain up to $125 million through various milestone payments, alongside tiered royalties on future sales. In addition to South Korea, Lotus has exclusive rights to develop and commercialize VIZZ in several other Southeast Asian nations, including Thailand, Vietnam, and Singapore. This underscores Lotus' strategy to leverage its established market presence to ensure an efficient launch and maximize accessibility for patients living with presbyopia.
Comments from Leadership
Petar Vazharov, CEO of Lotus, expressed pride in the MFDS submission, highlighting its importance for their strategy in South Korea, which is a crucial market for Lotus. He stated, "This filing supports our strategy to expand our current portfolio by using our established commercial capabilities. VIZZ is a transformative option for many people with presbyopia, and we are dedicated to working with regulators to expedite its availability to patients."
Adding to this sentiment, Eef Schimmelpennink, President and CEO of LENZ Therapeutics, emphasized their commitment to collaboration with partners like Lotus, noting the completion of the MFDS filing as an essential step in making VIZZ accessible to patients across Asia.
Understanding Presbyopia and VIZZ's Role
Presbyopia is a natural part of aging that affects nearly everyone over 45, resulting in difficulty focusing on close objects. This gradual decline in near vision can significantly affect daily activities, often necessitating corrective measures. VIZZ represents a new approach for adults with presbyopia, offering patients the chance to regain clear near vision through its innovative formulation.
What is VIZZ?
VIZZ is a once-daily ophthalmic solution that helps restore clear near vision for up to 10 hours. Its active ingredient, aceclidine, provides both rapid and lasting improvement in vision. VIZZ is preservative-free and comes in convenient single-dose vials. The product works by inducing a pinhole effect, which aids in enhancing depth of focus, thus improving the patient’s ability to see nearby objects clearly.
VIZZ Safety Information
The safety profile of VIZZ has been thoroughly examined in clinical trials. While generally well-tolerated, it is important to note that some individuals may experience mild side effects such as eye irritation or temporary dimming of vision. Therefore, users are advised to handle the product carefully and consult a healthcare provider if significant issues arise.
About LENZ Therapeutics
LENZ Therapeutics is at the forefront of developing innovative ophthalmic treatments aimed at improving the quality of life for millions suffering from vision impairments. With a focus on VIZZ, the first FDA-approved aceclidine-based eye drop for presbyopia, LENZ aims to make significant strides in vision care, targeting the growing population affected by this condition worldwide. Located in San Diego, California, LENZ is committed to making VIZZ accessible to patients across multiple international markets.
About Lotus Pharmaceutical
Founded in 1966, Lotus Pharmaceutical stands as a key player in the pharmaceutical industry with a significant global reach. The company specializes in both innovative and generic medicines, emphasizing safer and more effective treatment options. Lotus maintains a robust R&D and manufacturing platform certified by various global authorities, reflecting its commitment to quality and patient care. The company’s diverse portfolio showcases its dedication to addressing various health needs, reinforcing its position in the competitive pharmaceutical landscape.
Frequently Asked Questions
What is the purpose of the NDA submission by LENZ and Lotus?
The NDA submission aims to gain approval for VIZZ, an eye drop treatment for presbyopia, allowing it to be marketed in South Korea.
What are the notable findings from the clinical studies of VIZZ?
VIZZ was shown to improve near vision within 30 minutes, lasting up to 10 hours, with minimal adverse effects reported in clinical trials.
How does VIZZ improve vision?
VIZZ works by creating a pinhole effect in the eye, which enhances depth of focus and allows clearer near vision for individuals with presbyopia.
What are the most common side effects associated with VIZZ?
Common side effects include mild site irritation, dim vision, and headaches, with most reactions being transient and self-resolving.
What is LENZ Therapeutics' goal with VIZZ?
LENZ aims to expand global access to VIZZ and provide an effective treatment option for millions suffering from the effects of presbyopia.
