Lenz Therapeutics, Corxel Pharmaceuticals report topline data from JX07001 trial

Corxel Pharmaceuticals and Lenz Therapeutics (LENZ) announced topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. In this China Phase 3 safety and efficacy trial, LNZ100 achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity, or BCDVA, at near, and maintaining their optimal distance visual acuity. More results showed: Rapid onset: 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes respectively. Three hours post treatment: 88% and 74% achieved two-lines and three-lines or greater improvement at three hours respectively, and maintained their optimal distance visual acuity. Long duration: 61% and 30% achieved two-lines and three-lines or greater improvement at 10 hours respectively. LNZ100 was well-tolerated with no serious treatment-related adverse events observed in the trial. The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study, including a four-week efficacy study followed by a five-month extension safety study, designed to evaluate the efficacy and safety of LNZ100 in participants with presbyopia. The objectives were to assess the potential of LNZ100 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles. The trial has enrolled 300 participants, with a broad enrollment criteria of between 45 and 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.