Lenz Therapeutics and Corxel Pharmaceuticals have announced positive topline data from their Phase 3 JX07001 clinical trial of LNZ100 for the treatment of presbyopia in China. The study showcased statistically significant improvements in near visual acuity without compromising distance vision, marking a potential advancement in the management of this age-related vision condition.
The Phase 3 trial evaluated the safety and efficacy of LNZ100 (1.75% aceclidine HCl) in patients with presbyopia. The primary endpoint was achieved, with participants demonstrating a statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, while maintaining optimal distance visual acuity (defined as not losing five or more letters).
Visual Acuity Improvements
The data indicated notable improvements in visual acuity at various time points following treatment. Specifically, 84% and 69% of participants achieved two-line and three-line improvements, respectively, at 30 minutes post-treatment. At three hours post-treatment, 88% and 74% demonstrated similar improvements. Even at 10 hours post-treatment, 61% and 30% of participants maintained two-line and three-line improvements, respectively.
Safety and Tolerability
LNZ100 was reported to be well-tolerated among the study participants, with no serious treatment-related adverse events observed throughout the trial. This favorable safety profile is a crucial factor for a treatment intended for chronic use in a generally healthy population.
Patient Perception
An additional finding from the trial was that 91% of participants reported noticing an improvement in their near vision following the administration of LNZ100. This subjective improvement aligns with the objective visual acuity data, reinforcing the potential benefit of this treatment.
Implications for Presbyopia Treatment
Presbyopia, the gradual loss of the ability to see objects clearly up close, affects a significant portion of the aging population. Current treatment options include reading glasses or surgery, but pharmacological interventions offer a non-invasive alternative. The positive results from this Phase 3 trial suggest that LNZ100 could provide a valuable option for individuals seeking to improve their near vision without compromising distance vision.
