LENZ Therapeutics’ LNZ100 Shows Promising Results in China Phase 3 Trial for Presbyopia
LENZ Therapeutics, a company focused on developing innovative treatments for eye conditions, has announced positive topline data from the Phase 3 JX07001 trial of its lead drug candidate, LNZ100, in patients with presbyopia in China. Presbyopia, a common age-related condition, affects the ability to focus on nearby objects.
The China Phase 3 trial, designed to assess the safety and efficacy of LNZ100 (1.75% aceclidine HCl), achieved its primary endpoint and key secondary endpoints. The results showed statistically significant improvements in Best Corrected Distance Visual Acuity (BCDVA) at near, meaning participants could see objects close up more clearly. Importantly, the treatment also maintained optimal distance vision, ensuring that patients didn’t lose their ability to see far away objects.
The data revealed that a substantial percentage of participants experienced significant improvements in their near vision:
* 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes, respectively.
* 88% and 74% achieved two-lines and three-lines or greater improvement at 3 hours, respectively, while maintaining their optimal distance visual acuity.
* 61% and 30% achieved two-line and three-line or greater improvement at 10 hours, respectively.
Furthermore, LNZ100 was well-tolerated, and no serious treatment-related adverse events were observed during the trial.
Building Momentum for Potential Approval
These positive results add to the growing body of evidence supporting LNZ100’s efficacy and safety. They echo the findings from previous trials, including the CLARITY studies, which were conducted in different regions and with participants of different ethnicities. This consistency further strengthens the product’s profile and suggests it could meet real-world performance expectations if approved.
The news comes as LENZ Therapeutics awaits a decision from the U.S. Food and Drug Administration (FDA) on its marketing application for LNZ100 for presbyopia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100. This means a decision is expected by that date.
William Blair, an investment bank, highlights that these positive results could benefit LENZ in its negotiations with potential partners for other regions outside the United States. This could lead to additional funding sources for the company.
Market Impact
Presbyopia is a global issue, affecting an estimated 1.8 billion people worldwide, including 128 million in the U.S. alone. If approved, LNZ100 could become a significant treatment option for this large patient population.
LENZ Therapeutics’ stock price has surged in response to these positive developments. The company’s shares are up over 450% since the announcement, reflecting investor confidence in LNZ100’s potential.
The promising results from the China Phase 3 trial, coupled with the FDA’s ongoing review of LNZ100, suggest that LENZ Therapeutics is on track to potentially offer a game-changing treatment for presbyopia.
