LENZ Therapeutics has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LNZ100, an aceclidine-based eye drop, for the treatment of presbyopia. This condition affects an estimated 1.8 billion people globally and 128 million in the United States, marking a significant unmet medical need. The submission is a pivotal step for LENZ, potentially offering a novel therapeutic option for those with age-related near vision loss.
The NDA is supported by data from the Phase 3 CLARITY study, a registration-enabling trial that evaluated the efficacy and safety of LNZ100. The study met all primary and secondary endpoints, demonstrating a statistically significant improvement in near vision. Specifically, participants treated with LNZ100 achieved three lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity.
Clinical Efficacy and Safety
The Phase 3 CLARITY study monitored over 30,000 treatment days and showed that LNZ100 was well-tolerated, with no serious treatment-related adverse events reported. This safety profile, combined with the efficacy data, supports the potential of LNZ100 as a best-in-class, pupil-selective, and long-acting therapeutic for presbyopia.
Management Perspective
"The submission of our NDA for LNZ100 is a significant milestone for LENZ and is a testament to the tremendous focus, execution and collaboration of our team," said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. "We believe LNZ100 has the potential to be best-in-class as a pupil-selective and long-acting therapeutic option for the treatment of presbyopia. We look forward to working alongside the FDA through this review process."
Regulatory Review Process
The FDA will conduct a 60-day filing review period to assess the completeness and acceptability of the NDA. This initial review will determine whether the application is sufficient to warrant a comprehensive evaluation by the agency.
About LNZ100
LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. It is designed to improve near vision in patients with presbyopia by selectively stimulating muscarinic receptors in the iris sphincter, leading to pupil constriction and improved depth of focus.
