Lenz Therapeutics announces FDA acceptance of NDA for LNZ100

LENZ Therapeutics (LENZ) announced that the U.S. Food and Drug Administration, FDA, has accepted the Company’s New Drug Application, NDA, 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. The FDA has assigned a Prescription Drug User Fee Act, PDUFA, target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. The NDA submission for the treatment of presbyopia is supported by the positive data results from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and is not approved for the treatment of presbyopia in any country.