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US-based LENZ Therapeutics, Inc. and Taiwan's Lotus Pharmaceutical have announced an exclusive license and commercialisation agreement for Lotus to commercialise LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia.
LENZ Therapeutics is a pre-commercial stage biopharmaceutical company focused on the development and commercializ\sation of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia. Lotus is a leading global pharmaceutical company focused on commercializ\sing novel pharmaceuticals to provide patients with better, safer and more accessible medicines.
Under the terms of the licensing and commercialization agreement, LENZ will receive up to $125 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. Lotus will have exclusive development, manufacturing, registration and commercialisation rights for LNZ100 for the treatment of presbyopia in the Republic of Korea and certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore.
In October 2024, LENZ announced that the FDA accepted the NDA for LNZ100 for the treatment of presbyopia, a condition that impacts an estimated 1.8 billion people globally and 128 million people in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100, and noted it is not planning to hold an Advisory Committee Meeting to discuss this application.
