LENZ Therapeutics’ China partner, Ji Xing Pharmaceuticals, was cleared by the Center for Drug Evaluation of the National Medical Products Administration of the PRC to conduct a Phase 3 clinical trial of LNZ100 (aceclidine) eye drops and LNZ101 (aceclidine/brimonidine) eye drops for the treatment of presbyopia in China.
LNZ100 and LNZ101 are being developed by LENZ. Ji Xing acquired the Greater China rights for the development and commercialization of the products in April 2022. There are no approved drugs for the treatment of presbyopia in China.
Aceclidine is a small molecule acetylcholine receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves age-related near vision, or presbyopia.
Aceclidine is the first and only pupil-reducing drug under development that selectively activates the muscarinic acetylcholinergic receptors on the pupillary sphincter. LNZ100 and LNZ101 have best-in-class potential, given the unique pupil selective mechanism of action and safety profile allowing to potentially target a broad patient population.
The Phase 3, multicenter, randomized, controlled, double-masked study is designed to assess the potential of LNZ100 and LNZ101 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles. The trial is expected to enroll 300 subjects, randomized on a 1:1:1 basis to receive LNZ100, LNZ101 or placebo.
Larry Li, M.D., Ph.D., CMO of ophthalmology at Ji Xing, said Phase 2 studies have shown the potential for LNZ100 and LNZ101 to be best-in-class. The approved Phase 3 clinical trial is expected to be the largest study and with the highest innovation potential Phase 3 program in the field of presbyopia in China, he added.
Current treatments for presbyopia include spectacles or surgery and there is huge unmet medical need for non-invasive, reversible pharmacological treatments, said Professor Jia Qu, principal investigator of the LNZ100/101 Phase 3 study in China, and vice chairman of ophthalmology branch, Chinese Medical Association, director of optometry department, Wenzhou Medical University.
“LNZ100 and LNZ101 have a unique pupil selective mechanism of action and we expect the new products to bring a new treatment option with long-lasting efficacy, good safety profile and convenience for over 400 million presbyopia patients in the future,“ Prof. Jia Qu said.
