Corxel Pharmaceuticals and LENZ Therapeutics have announced positive topline data from the Phase 3 JX07001 clinical trial evaluating LNZ100 (1.75% aceclidine HCl) for the treatment of presbyopia in Chinese patients. The study met its primary endpoint, demonstrating a statistically significant improvement in near vision without compromising distance vision.
Key Findings from the Phase 3 Trial
The Phase 3 trial, a multicenter, randomized, double-blind, vehicle-controlled study, included 300 participants aged 45 to 75. The results indicated that LNZ100 led to a clinically meaningful improvement in near visual acuity. Specifically, patients experienced an improvement of three lines or more in best-corrected distance visual acuity (VA) at near, while maintaining optimal distance VA (defined as no loss of 5 or more letters).
Additional key findings include:
- Rapid Onset: 84% and 69% of patients achieved 2-line and 3-line or greater improvement, respectively, within 30 minutes of instillation (P < 0.0001).
- Sustained Effect: At 3 hours post-treatment, 88% and 74% achieved 2-line and 3-line or greater improvements, respectively, while maintaining optimal distance VA (P < 0.0001).
- Long Duration: 61% and 30% achieved 2-line and 3-line or greater improvement at 10 hours, respectively (P < 0.0001).
- Safety: LNZ100 was well-tolerated, with no serious treatment-related adverse events reported.
Expert Commentary
Eef Schimmelpennink, President and CEO of LENZ Therapeutics, stated, "We are pleased with the impressive and consistent performance demonstrated by LNZ100 in our collective studies, further validating the vision of targeting an 'all eyes, all day' solution." He added that the data enhances LNZ100's potential as a global therapy, especially in China, where an estimated 400 million people have presbyopia.
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... 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."
Mechanism of Action
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 that aceclidine, the active ingredient in LNZ100, causes temporary pupil constriction, extending the depth of focus and improving vision quality. The statistically significant and clinically meaningful outcomes support the efficacy and safety of LNZ100 as a practical treatment option for improving near vision in the Chinese presbyopia population.
Implications for Presbyopia Treatment
These findings suggest that LNZ100 could offer a non-invasive and reversible treatment option for presbyopia, addressing a significant unmet need in China, where current treatments primarily involve eyeglasses.
