Corxel Pharmaceuticals and Lenz Therapeutics have announced positive topline data from their Phase 3 clinical trial in China evaluating LNZ100 for the treatment of presbyopia. The study, which involved 300 participants aged 45-75, demonstrated statistically significant improvements in near vision, marking a potential advancement in non-invasive presbyopia treatment.
Primary Endpoint Achieved
The Phase 3 trial met its primary endpoint, with 74% of participants achieving a three-line or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at 3 hours post-treatment. This improvement was observed while maintaining optimal distance visual acuity, indicating that LNZ100 effectively improves near vision without compromising distance vision.
Rapid Onset and Sustained Duration
LNZ100 demonstrated a rapid onset of action, with 69% of participants achieving a three-line or greater improvement in near vision within 30 minutes of administration. The treatment also showed sustained efficacy, with 30% of participants maintaining this level of improvement at 10 hours post-treatment. These results suggest that LNZ100 could provide a convenient and effective solution for individuals with presbyopia.
Safety and Tolerability
The trial reported that LNZ100 was well-tolerated, with no serious treatment-related adverse events observed. This favorable safety profile is crucial for a treatment intended for long-term use in a generally healthy population.
Clinical Significance
Professor Jia Qu, Principal Investigator and Co-Principal Investigator, Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University, stated, "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."
Professor Fan Lyu, Principal Investigator and Co-Principal Investigator，Head of optometry working-group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases said: "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."
Implications for Presbyopia Treatment
Presbyopia, a common age-related condition affecting an estimated 400 million people in China alone, results in a gradual decline in the ability to focus on near objects. Current treatment options are limited, with many patients relying on eyeglasses. LNZ100 offers a potential non-invasive alternative that could significantly improve the quality of life for individuals with presbyopia.
Regulatory Pathway
The FDA has accepted the New Drug Application for LNZ100 in the United States, with a PDUFA target action date of August 8, 2025. The positive results from the China Phase 3 trial further support the potential for LNZ100 to become a globally available therapy for presbyopia.
Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics, commented, "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."
