LENZ Therapeutics announces positive topline results from Phase 3 CLARITY study

(Image Credit: AdobeStock/Alexander Raths)

LENZ Therapeutics has announced positive topline results from its Phase 3 CLARITY study of 2 investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia.

The company stated that results showed LNZ100 (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, while LNZ101 showed similar results but ultimately failed to show superiority to LNZ100. The primary efficacy endpoint in both CLARITY 1 and 2 was the percentage of participants who achieve 3-lines or greater improvement in BCDVA at near without losing 1-line (5 letters or more of distance vision) at 3 hours post-treatment.¹

More details on the results showed that LNZ100 achieved a statistically significant 3-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing 1-line or more in distance visual acuity. According to the results, 71% achieved 3-lines or greater improvement at 30 minutes while 40% achieved 3-lines or greater improvement at 10 hours.¹

On day 223 of the CLARITY 1 and 2 trials, 223 recipients were surveyed who received LNZ100 and 90% stated they noticed an improvement in their near vision and 75% said they would want to continue to use LNZ100 after the study, of which 81% noted they expected to use them 4-7 days a week.¹

Furthermore, it was specified that LNZ100 was well-tolerated with no serious treatment-related adverse events observed across all 3 CLARITY trials.

CLARITY is a Phase 3, multi-center double-masked, randomized, controlled, efficacy and safety study.

Eef Schimmelpennink, President and CEO of LENZ Therapeutics, talked about the success of the trials in a press release from the company. It is comprised of the CLARITY 1 and 2, which are 2, 6-week efficacy trials as well as the CLARITY 3, a 6-month safety trial. A total of 1,059 patients were enrolled across the trials ranging from ages 45 to 75.

“We are very pleased with the outcome of the CLARITY trials, and most importantly the strong efficacy and safety profile of LNZ100 observed in patients with presbyopia,” said Schimmelpennink. “We believe these data support LNZ100 as a potential best-in-class therapy for the treatment of presbyopia. The high responder rate, rapid onset and long duration across a broad range of presbyopes ranging from 45 to 75 years of age and having a refractive range from -4.0 to +1.0D SE are consistent with features that patients are expecting from an effective treatment option. Based on these highly encouraging data, we will direct our focus towards our NDA submission in mid-2024 for LNZ100, and preparations for commercialization in second half of 2025 upon FDA approval, with the goal of moving closer to helping many of the 128 million people experiencing symptoms of presbyopia in the United States.”

Based on the results, the company has stated that LNZ100 will be the lead candidate moving forward and plans to submit a New Drug Application (NDA) with the FDA are in place for mid-2024.

References:

1. LENZ Therapeutics Announces Positive Topline Data from Phase 3 CLARITY Presbyopia Trials. Press release; April 3, 2024. Accessed April 9, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/11/lenz-therapeutics-announces-positive-topline-data-from-phase-3-clarity-presbyopia-trials