CORXEL and LENZ Report Positive China Phase 3 Presbyopia Trial Results for LNZ100

Corxel Pharmaceuticals and LENZ Therapeutics have announced positive results from their Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. The trial, conducted to assess the safety and efficacy of LNZ100, an aceclidine-based eye drop, has shown promising outcomes, potentially positioning LNZ100 as a leading non-invasive treatment for presbyopia.

The primary endpoint of the study was met, with 74% of participants experiencing an improvement of three lines or more in their near vision three hours after treatment, while maintaining their optimal distance visual acuity. This was significantly better compared to the vehicle group, with a statistical significance of p<0.0001. Furthermore, the treatment exhibited rapid onset and long duration of action, with 69% of participants showing improvement as early as 30 minutes post-treatment and 30% maintaining the improvement at 10 hours. Additionally, 91% of participants reported noticeable improvement in their near vision.

The trial was a multicenter, randomized, double-blind, vehicle-controlled study, including a 4-week efficacy phase followed by a 5-month safety extension. A total of 300 participants aged 45 to 75, with a refractive range of -4.0D SE to +1.0D SE, including those with previous laser-assisted corneal refractive surgery or monofocal IOL implantation, were enrolled. The study confirmed the efficacy and safety profile of LNZ100, with no serious treatment-related adverse events observed.

Professor Jia Qu, Vice Chairman of the Ophthalmology Branch of the Chinese Medical Association, expressed satisfaction with the trial results, highlighting the significant efficacy and favorable safety profile of LNZ100. He emphasized the existing unmet need for non-invasive treatments for presbyopia, currently managed primarily through eyeglasses. Professor Fan Lyu, Head of the Optometry Working Group under the Ophthalmology Branch of the Chinese Medical Association, elaborated on the mechanism of action of aceclidine, the active ingredient in LNZ100, which causes temporary pupil constriction, thereby improving the depth of focus and quality of vision.

Sandy Mou, CEO of Corxel Pharmaceuticals, expressed gratitude to the researchers, partners, and volunteers involved in the study. Mou emphasized the potential of LNZ100 to meet the substantial unmet medical need for presbyopia treatment in China and projected an expedited path toward regulatory submission and approval. Eef Schimmelpennink, CEO of LENZ Therapeutics, echoed these sentiments, highlighting the consistent performance of LNZ100 and its potential as a global therapy.

Presbyopia is a common age-related condition that impairs the ability to see nearby objects clearly. It is caused by the gradual hardening of the lens, leading to a decline in the eye's ability to focus on close objects. The condition typically begins to manifest around the age of 38 and affects nearly 100% of the population by age 52 in China. Current treatment options are limited, with eyeglasses being the primary solution, while surgical options are less favored due to their invasive and irreversible nature. There are no approved drugs for presbyopia in China, highlighting the significant demand for non-invasive, safe, and effective treatments.

LNZ100, developed by LENZ Therapeutics, is designed to achieve optimal pupil diameter without affecting distance vision, a limitation of other miotic treatments. Unlike other miotics such as pilocarpine and carbachol, aceclidine selectively activates the iris sphincter muscle to achieve pupil constriction, thereby improving near vision without overstimulating the ciliary muscles. This makes LNZ100 suitable for a broad range of presbyopia patients, including older individuals who have lost the accommodation capacity of the lens.

Corxel, founded in 2019 and backed by RTW Investments, focuses on developing and commercializing innovative therapeutics for unmet medical needs, particularly in cardiometabolic diseases. Its portfolio includes global and Greater China rights to several late-stage clinical assets. LENZ Therapeutics, based in San Diego, is dedicated to developing aceclidine-based eye drops for presbyopia, with LNZ100 being their lead product candidate currently under review by the U.S. FDA.

The successful Phase 3 trial of LNZ100 in China marks a significant milestone in the quest for an effective, non-invasive treatment for presbyopia, potentially benefiting millions of patients globally.