LENZ Therapeutics submits NDA for LNZ100 for the treatment of presbyopia

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Biopharmaceutical company LENZ Therapeutics announced that it has submitted a New Drug Application (NDA) to the US FDA for LNZ100, an aceclidine-based ophthalmic solution for the treatment of presbyopia, according to a news release. The FDA will have 60 days for a filing review period to determine whether the submission is complete and acceptable to review.¹

“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 CEO 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.”

Positive data from the pivotal Phase 3 CLARITY study supports the NDA submission. The study provided statistically significant results, with participants reaching 3-lines or greater improvement in Best Corrected Distance Visual Acuity at near and did not lose 1 line or more in distance visual acuity. In addition to reaching all primary and secondary near vision improvement endpoints, the study also demonstrated LNZ100 as well tolerated with no serious treatment-related adverse events in more than 30000 treatment days.¹

Reference:

1. Lenz Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia. News release. Lenz Therapeutics. August 12, 2024. Accessed August 12, 2024.