Positive Phase 3 Results: LENZ's CLARITY Trial for Presbyopia Treatment

LENZ Therapeutics, a biopharmaceutical firm, has announced the successful results from its Phase 3 CLARITY study, which evaluated the effectiveness of two formulations of aceclidine, LNZ100 and LNZ101, in treating presbyopia. Presbyopia is a common age-related condition that leads to a decline in near vision, affecting nearly all individuals over the age of 45.
The study's primary focus was on LNZ100, which demonstrated significant improvements in Best Corrected Distance Visual Acuity (BCDVA) at near without compromising distance vision. Notably, 71% of participants treated with LNZ100 experienced a rapid onset of improvement within 30 minutes, and the same percentage showed a three-line or greater improvement at 3 hours. Additionally, 40% of participants maintained this level of improvement up to 10 hours post-treatment.
The trials were well-tolerated, with no serious treatment-related adverse events reported over 30,000 treatment days across all three CLARITY trials. LNZ101 also met its endpoints but did not outperform LNZ100. Consequently, LENZ has chosen LNZ100 as its primary product candidate, with plans to submit a New Drug Application (NDA) to the FDA in mid-2024.
LENZ Therapeutics' President and CEO, Eef Schimmelpennink, expressed satisfaction with the trial outcomes, highlighting the strong efficacy and safety profile of LNZ100. He emphasized the potential of LNZ100 as a best-in-class therapy for presbyopia, noting its high responder rate, rapid onset, and long-lasting effects. The company aims to help the estimated 128 million people in the United States experiencing presbyopia symptoms.
Marc Odrich, LENZ's Chief Medical Officer, commented on the significance of the data, stating that presbyopia can significantly disrupt daily life as symptoms intensify from the mid-40s. The positive CLARITY study results reinforce the safety and efficacy profile of aceclidine in treating presbyopia and suggest that LNZ100 could offer a convenient alternative to reading glasses.
The CLARITY study included two six-week efficacy trials and a six-month safety trial, enrolling 1,059 participants aged 45 to 75. The primary efficacy endpoint was the percentage of participants achieving a three-line or greater improvement in BCDVA at near without losing one line of distance vision at 3 hours post-treatment. LNZ100 met all primary and secondary endpoints, showing rapid onset and long duration of near vision improvement.
LENZ Therapeutics anticipates presenting more detailed results from the CLARITY study at future medical conferences. The company also hosted a conference call and webcast to discuss the study's topline results.