Aceclidine

July 28, 2025 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ, “LENZ” or the “Company”), a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that CORXEL Pharmaceuticals (“CORXEL”) has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC). LENZ licensed the Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022. The NDA submission was supported by positive data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one-line or more in distance visual acuity. The submission of the NDA for LNZ100 results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL (the “License”). Under the terms of the License, LENZ is eligible to receive up to $95.0 million of regulatory and sales milestones, as well as tiered mid single-digit to low double-digit royalties on net sales in Greater China. “This exciting milestone in our development partnership with CORXEL has come as a result of tremendous collaboration between the teams,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “This submission was supported by the impressive data generated from the Phase 3 clinical trial of LNZ100 in China, consistent with the data from the CLARITY trial. This is the first regulatory submission outside of the United States, further reinforcing the opportunity for LNZ100 to become a global therapy for the treatment of presbyopia.” LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. The content above comes from the network. if any infringement, please contact us to modify.

July 07, 2025 -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Laboratoires Théa (“Théa”) announced an exclusive license and commercialization agreement for Théa to register and commercialize LNZ100 for the treatment of presbyopia in Canada. LENZ Therapeutics is a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, which has a US FDA PDUFA date of August 8, 2025. Théa is an independent pharmaceutical company specialized in the research, development and commercialization of eye-care products. Under the terms of the licensing and commercialization agreement, LENZ will be eligible to receive over $70 million in upfront, regulatory and commercial milestone payments, as well as tiered, double-digit royalties on net sales. Théa will have exclusive development, manufacturing, registration and commercialization rights for LNZ100 for the treatment of presbyopia in Canada. “Théa is a leading company in eyecare in key markets around the world and was a natural choice for LENZ when looking for a highly capable commercial partner in Canada. With its strong position in commercializing eye drops, Théa is uniquely positioned to bring the benefits of LNZ100 to patients in this key market,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “This agreement represents our third commercialization partnership outside the United States for LNZ100, as we continue to be focused on maximizing patient access to this important therapy worldwide.” Jean-Frédéric Chibret, President of Théa, commented: “Canada is an important part of Théa’s international development, and we have been active in the country for several years. Our local team plays an essential role in supporting both patients and eye care professionals. This partnership with LENZ will expand our portfolio with a promising therapy targeting a prevalent condition that affects millions of adults. We see strong potential for LNZ100 in Canada and look forward to initiating the registration process and making the treatment available to Canadian healthcare providers and their patients. 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. LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. Théa is the leading independent European pharmaceutical company specializing in the research, development, and commercialization of ophthalmic products. Headquartered in Clermont-Ferrand, France, this family-owned company employs over 2,000 people and has built a strong international presence through a network of more than 35 independent subsidiaries and offices across Europe, North Africa, the Americas, and the Middle East. All products are manufactured in Europe—60% in France—and are available in 75 countries worldwide. In 2024, Théa reported revenues of €970 million. The content above comes from the network. if any infringement, please contact us to modify.