Corxel Pharmaceuticals and Lenz Therapeutics have announced positive topline data from their Phase 3 JX07001 clinical trial of LNZ100 (1.75% aceclidine HCl) in Chinese patients with presbyopia. The study, designed to evaluate the efficacy and safety of LNZ100, met its primary and key secondary endpoints, demonstrating a clinically meaningful improvement in near vision while maintaining optimal distance vision.
The Phase 3 trial included 300 participants aged 45 to 75 years, with refractive errors ranging from -4.0 to +1.0 diopters. The study featured a 4-week efficacy assessment followed by a 5-month extension for safety monitoring. The primary endpoint was achieving a three-line or more improvement in best-corrected distance visual acuity (VA) at near, without losing five or more letters in distance VA.
Key Findings
The results indicated a rapid onset of action, with 84% and 69% of patients achieving 2-line and 3-line or greater improvement, respectively, just 30 minutes post-instillation. At 3 hours post-treatment, 88% and 74% achieved 2-line and 3-line or greater improvements, respectively, while maintaining their optimal distance VA. The effects were also shown to be long-lasting, with 61% and 30% achieving 2-line and 3-line or greater improvement at 10 hours, respectively. All these results reached statistical significance (P < 0.0001).
According to Eef Schimmelpennink, President and Chief Executive Officer of Lenz Therapeutics, the data further validates the vision of targeting an 'all eyes, all day' solution. He added, "With this data, we believe LNZ100 has further enhanced its potential as a global therapy and is further on its path towards providing access to the estimated 400 million people with presbyopia in China."
Safety and Tolerability
LNZ100 was well-tolerated among the study participants, with no serious treatment-related adverse events reported. This favorable safety profile is consistent with previous studies, including Lenz Therapeutics' CLARITY study.
Expert Commentary
Professor Jia Qu, Principal Investigator and Co-Principal Investigator, Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University, commented, "We are very pleased with the results of the LNZ100 trial, particularly the significant efficacy and favorable safety profile of LNZ100 in patients with presbyopia, demonstrating an important advance in the field of presbyopia treatment in China. Currently, patients mainly rely on wearing eyeglasses as treatment for presbyopia. There is a large unmet need for non-invasive and reversible treatments. We expect that LNZ100 will fill this vacuum and become an innovative force in the treatment of presbyopia in China, providing more patients with the hope of clear vision."
Professor Fan Lyu, Principal Investigator and Co-Principal Investigator, Head of the Optometry Working-Group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases, explained the drug’s mechanism of action: "The main active ingredient of LNZ100, aceclidine, causes temporary pupil constriction, resulting in an optical effect that significantly extends the depth of focus and improves the quality of vision. The statistically significant data and clinically meaningful outcomes observed in the trials provide strong support for the efficacy and safety of LNZ100. We anticipate that LNZ100 will be a practical treatment option for a wide spectrum of patients and will have a favorable impact on paradigm shift of helping improve near-vision in the Chinese presbyopia population."
