Lenz Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for LNZ100, a potential treatment for presbyopia. This condition affects an estimated 1.8 billion people globally and 128 million in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100 and does not plan to hold an advisory committee meeting to discuss the application.
The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study. Aceclidine, the active ingredient in LNZ100, is a new chemical entity in the United States and is not currently approved for presbyopia treatment in any country.
Clinical Significance of LNZ100
LNZ100 is designed as a preservative-free, single-use, once-daily eye drop containing aceclidine. The Phase 3 CLARITY study evaluated its efficacy and safety as a potential therapy for presbyopia. The company aims to provide a convenient pharmaceutical solution that enhances vision throughout the day for individuals with presbyopia.
Management Commentary
Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics, stated, "With the acceptance of our New Drug Application for LNZ100, we are pleased to be one step closer towards potential approval and look forward to continuing to collaborate with the FDA to deliver the first once-daily, well-tolerated and rapid acting eye drop for the treatment of presbyopia to the 128 million individuals living with blurry near vision in the United States."
Shawn Olsson, Chief Commercial Officer, added, "This is an important milestone as we advance our commercial preparations in anticipation of a potential approval in August 2025. With a highly accomplished commercial leadership team in place, we look forward to the continued build-out of our commercial organization with an aim to clearly define the market and establish LNZ100 as the standard of care eye drop for the treatment of presbyopia."
About Presbyopia
Presbyopia is an age-related condition that results in a gradual loss of the ability to focus on nearby objects. It is a common vision disorder affecting a significant portion of the adult population worldwide.
