LNZ100 (1.75% Aceclidine) Ophthalmic Solution Submitted for Approval in China as First-in-Class Presbyopia Treatment

Jul 29, 2025 20:30 CST Updated 20:30

LENZ Therapeutics

Ophthalmic Drug Product Developer

CORXEL

Developer of Oral Small Molecule Cardiac Myosin Inhibitors

July 28,LENZ TherapeuticsAnnouncing PartnershipsCORXEL PharmaceuticalsSubmitted in ChinaLNZ100 Eye Drops (1.75% Aceclidine)The listing application for the treatment of presbyopia (Commonly known as "presbyopia"）。If successfully approved, the drug will become the first in ChinaThe first eye drop for improving near vision in patients with presbyopia.

LNZ100YesDeveloped by LENZ TherapeuticsA preservative-free, usage frequency ofDaily 1Acclidine Acetate Ophthalmic Solution.Aceclidine can cause temporary pupil constriction, thereby producing significant optical effects of prolonged viewing distance, improved near vision, and enhanced visual quality.Unlike other miotics such as pilocarpine and carbachol, the mechanism of action of aceclidine is pupil-selective, meaning it can activate the iris sphincter to constrict the pupil to a diameter of less than 2 millimeters without overstimulating the ciliary muscle, which could lead to myopic shifts and impaired distance vision. Therefore, aceclidine does not require any residual accommodation to improve near vision, thereby expanding its benefits for elderly presbyopes who have lost their lens accommodation capability.In April 2022, LENZ Therapeutics entered into an exclusive licensing agreement with CORXEL for the development and commercialization of LNZ100 and LNZ101 for the treatment of presbyopia in Greater China.

This marketing application is supported by the Phase III JX07001 study. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial consisting of a 4-week efficacy trial and a total 6-month safety trial, aimed at observing the improvement of near vision in Chinese presbyopic patients by LNZ100 and confirming its efficacy and safety. A total of 300 subjects were enrolled in the study, with eligible subjects aged between 45 and 75 years, having a refractive range of -4.0D SE to +1.0D SE, including those who had previously undergone laser vision correction surgery or monofocal intraocular lens implantation surgery.

The results showed that the study met the primary endpoint and key secondary endpoints, namelyLNZ100 Group SubjectsNear visual acuity (BCDVA) under optimal distance correction shows a significant improvement of three lines or more, while maintaining the best distance visual acuity (i.e., vision loss should not exceed five letters).

More study results also showed (all p-values were less than 0.0001):

Rapid Onset: 84% and 69% of subjects achieved two-line and three-line or better near visual acuity improvement, respectively, within 30 minutes after medication.

Three Hours After Medication: 88% and 74% of subjects achieved two-line and three-line improvements or better in near visual acuity, respectively, while maintaining their best distance vision (i.e., with a decrease of no more than five letters).

Long-lasting efficacy: 61% and 30% of subjects maintained two-line and three-line or better near visual acuity improvement, respectively, at 10 hours post-dose.

Presbyopia refers to the physiological phenomenon where, with age, seeing nearby objects gradually becomes blurred. The reason is the gradual hardening and reduced elasticity of the eye's lens, leading to a decline in the eye's accommodative function, making it unable to focus the image of nearby objects on the retina, resulting in decreased near vision. Presbyopia is an inevitable physiological phenomenon associated with aging. Research shows that in China, the onset age of presbyopia is around 38 years old, and by the age of 52, the incidence rate approaches 100%. It is estimated that in ChinaApproximately4100 Million CasesPresbyopia Patients。

Currently, there are very limited treatment options for presbyopia. Wearing glasses requires frequent removal and reapplication, causing significant inconvenience in work and daily life. Surgery, as an invasive and irreversible procedure, has very limited acceptance. Currently, no drugs for presbyopia treatment have been approved in China. In terms of non-invasive, safe, effective, and reversible drug treatments, there is a huge unmet medical need in the field of presbyopia.

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