Corxel Pharmaceuticals and LENZ Therapeutics announced positive topline data from their China Phase 3 clinical trial of LNZ100 (aceclidine 1.75% eye drops) for the treatment of presbyopia. The study, JX07001, met its primary endpoint, demonstrating a statistically significant improvement in near vision in participants treated with LNZ100 compared to the vehicle group (p<0.0001). This advancement addresses a significant unmet need for non-invasive presbyopia treatments in China, where over 400 million people are affected.
Efficacy and Safety Results
The Phase 3 trial enrolled 300 participants aged 45 to 75 with presbyopia. Key findings include:
- Primary Endpoint: 74% of participants achieved a three-line or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at 3 hours post-treatment, while maintaining optimal distance visual acuity.
- Rapid Onset: 69% of participants achieved a three-line or greater improvement within 30 minutes.
- Long Duration: 30% of participants maintained a three-line or greater improvement at 10 hours.
- Patient Satisfaction: 91% of participants reported noticing an improvement in their near vision.
The study also reported that LNZ100 was well-tolerated, with no serious treatment-related adverse events observed.
Expert Commentary
Professor Jia Qu, a principal investigator in the trial, noted, "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... 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."
Professor Fan Lyu, another principal investigator, added, "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... 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."
Trial Design and Patient Population
The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled trial. It included a 4-week efficacy study followed by a 5-month extension safety study. Participants ranged from 45 to 75 years of age with a refractive range of -4.0D SE to +1.0D SE, including those who had undergone laser-assisted cornea refractive surgery/monofocal IOL implantation.
About Presbyopia and LNZ100
Presbyopia is an age-related condition affecting nearly everyone over the age of 50, resulting in a gradual loss of the ability to focus on near objects. Current treatments are limited, with many patients relying on glasses. LNZ100 (aceclidine) eye drops are designed to improve near vision by causing pupil constriction, creating a pinhole effect that enhances focus without significantly impacting distance vision. Aceclidine's pupil-selective mechanism aims to avoid the myopic shift and impaired distance vision associated with other miotics like pilocarpine.
Future Directions
Corxel plans to actively communicate with drug regulatory authorities to expedite the submission and approval of LNZ100 in China. LENZ Therapeutics is also pursuing regulatory approval in the United States, with a PDUFA target action date of August 8, 2025.
