LENZ Therapeutics Announces NMPA Submission of ND for LNZ100 for Presbyopia Treatment


LENZ Therapeutics, Inc. recently announced CORXEL Pharmaceuticals 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 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 US. The US 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, CA. For more information, visit LENZ-Tx.com.