LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application.
LNZ100 is a preservative-free, single-use, once-daily eye drop that contains aceclidine, a novel compound with potential in treating presbyopia. The regulatory Phase III CLARITY study has demonstrated LNZ100’s rapid onset and good tolerability, indicating its potential as an effective treatment for presbyopia.
In April 2022, Ji Xing Pharmaceuticals, based in China, secured development and commercialization rights in Greater China for LENZ’s LNZ100 and LNZ101 (aceclidine + brimonidine) through a licensing deal valued at USD 120 million. This collaboration underscores the global interest in innovative presbyopia treatments and the potential market opportunity for LENZ’s product candidates.
The acceptance of the NDA filing for LNZ100 by the FDA is a significant milestone for LENZ Therapeutics, reflecting the company’s commitment to addressing unmet medical needs in the field of ophthalmology.- Flcube.com
