CORXEL submits NDA for LNZ100 in China for presbyopia treatment

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LENZ Therapeutics announced that CORXEL Pharmaceuticals has submitted the New Drug Application (NDA) for LNZ100 (1.75% aceclidine HCl) for the treatment of presbyopia to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC).

LENZ Therapeutics previously licensed Greater China rights to CORXEL for the development and commercialization of LNZ100 in April 2022.¹

In October 2024, LENZ announced that the US Food and Drug Administration (FDA) accepted the new drug application for LNZ100 for the treatment of patients with presbyopia.²

The NDA submission was supported by positive data from the phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. JX07001 was a multicenter, randomized, double-blind, vehicle-controlled study including a 4-week efficacy study followed by a 5-month extension safety study to evaluate the efficacy and safety of LNZ100 for treating presbyopia.

The trial included 300 participants between 45 and 75 years of age with a refractive range of -4.0 to +1.0 diopters of spherical equivalent, including those who had undergone laser-assisted cornea refractive surgery/monofocal intraocular lens implantation.³

The phase 3 safety and efficacy results showed that the drug met the primary endpoint and key secondary endpoints, with 3 lines or more of improvements in the best-corrected distance visual acuity (VA) at near, and the patients maintained their optimal distance VA, defined as no loss of 5 or more letters.³

The NDA submission to the NMPA results in the achievement of the first milestone under the License and Collaboration Agreement with CORXEL. 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.

Eef Schimmelpennink, president and CEO of LENZ Therapeutics, commented on the partnership in a press release from the company,¹ saying, “This exciting milestone in our development partnership with CORXEL has come as a result of tremendous collaboration between the teams. 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.”

Recently, LENZ Therapeutics and Laboratoires Théa announced a license and commercialization agreement for Théa to register and commercialize LNZ100 for the treatment of presbyopia in Canada.

References:

1. LENZ Therapeutics announces NMPA submission of New Drug Application for LNZ100 in China for the treatment of presbyopia. Published July 28, 2025. Accessed July 28, 2025. https://ir.lenz-tx.com/news-events/press-releases/detail/37/lenz-therapeutics-announces-nmpa-submission-of-new-drug-application-for-lnz100-in-china-for-the-treatment-of-presbyopia

2. Harp MD. LENZ Therapeutics and Laboratoires Théa partner to commercialize LNZ100 for presbyopia in Canada. Published July 8, 2025. Accessed July 28, 2025. https://www.ophthalmologytimes.com/view/lenz-therapeutics-and-laboratoires-th-a-partner-to-commercialize-lnz100-for-presbyopia-in-canada

3. Charters L. CORXEL and LENZ Therapeutics announce positive topline data from phase 3 presbyopia trial of LNZ100 in China. Published October 29, 2024. Accessed July 28, 2025. https://www.ophthalmologytimes.com/view/corxel-and-lenz-therapeutics-announce-positive-topline-data-from-phase-3-presbyopia-trial-of-lnz100-in-china