The FDA has accepted LENZ Therapeuitics’ New Drug Application (NDA) for LNZ 110 for the treatment of presbyopia. LNZ 100 is the first and only aceclidine-based eyedrop to improve near vision in those with presbyopia, the company says. Aceclidine is a new chemical entity in the United States and is not approved for the treatment of presbyopia in any country. The NDA submission is supported by the positive data results from the pivotal Phase 3 CLARITY study.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. Additionally, the agency noted that it is not planning to hold an advisory committee meeting to discuss this application, LENZ reported in a press release.