LENZ Therapeutics announces submission of New Drug Application to FDA for LNZ100 for treatment of presbyopia

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LENZ Therapeutics Inc announced that the Company has submitted a New Drug Application (NDA) to the FDA for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.

Eef Schimmelpennink, president and CEO of LENZ Therapeutics, pointed out in a news release the submission of the company’s NDA for LNZ100 is a milestone for the company and “is a testament to the tremendous focus, execution and collaboration of our team.”

“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,” Schimmelpennink added in the news release. “We look forward to working alongside the FDA through this review process.”

According to the company, its NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia.¹

The company stated that LNZ100 (1.75% aceclidine) achieved the primary endpoints and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity, demonstrating LNZ100 was well tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days monitored in the CLARITY study.¹

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.

Reference:

1. LENZ Therapeutics, Inc. LENZ Therapeutics, Inc. Published August 12, 2024. Accessed August 12, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/18/lenz-therapeutics-announces-submission-of-new-drug-application-to-u-s-food-and-drug-administration-for-lnz100-for-the-treatment-of-presbyopia