FDA Accepts LENZ Therapeutics' New Drug Application for LNZ100 to Treat Presbyopia

SAN DIEGO, Oct. 21, 2024 – LENZ Therapeutics, Inc., a pre-commercial biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for LNZ100, intended for the treatment of presbyopia. Presbyopia is a common condition that affects approximately 1.8 billion individuals worldwide, including 128 million in the United States. The FDA has established a Prescription Drug User Fee Act (PDUFA) target date of August 8, 2025, for the application. Notably, the FDA does not plan to conduct an advisory committee meeting to discuss the application.

Eef Schimmelpennink, President and CEO of LENZ Therapeutics, expressed satisfaction with the acceptance of their NDA, noting that it represents a significant step toward potential approval. Schimmelpennink highlighted the company's commitment to collaborating with the FDA to deliver the first once-daily, rapid-acting, and well-tolerated eye drop designed to treat presbyopia. Since its public introduction in March 2024, LENZ Therapeutics has made significant strides in clinical, regulatory, and financial areas, according to Schimmelpennink, and aims to transform into a strong commercial entity by potentially launching the product in the latter half of 2025.

The NDA submission for presbyopia treatment is backed by positive Phase 3 CLARITY study results. Aceclidine, the active ingredient in LNZ100, is a new chemical entity in the United States and has not been approved for presbyopia treatment in any country.

Shawn Olsson, Chief Commercial Officer, emphasized the importance of this milestone for the company’s commercial preparations, anticipating potential approval in August 2025. Olsson noted that with an experienced commercial leadership team, LENZ Therapeutics aims to clearly define the market and establish LNZ100 as the standard of care for presbyopia treatment.

LENZ Therapeutics is a San Diego-based biopharmaceutical company focused on developing and commercializing aceclidine-based eye drops to improve near vision for people with presbyopia. The company's product candidate, LNZ100, is a preservative-free, single-use, once-daily eye drop evaluated in the Phase 3 CLARITY study. The FDA has assigned a PDUFA target action date of August 8, 2025, for LNZ100.

In summary, LENZ Therapeutics is advancing its efforts to provide an innovative solution for presbyopia, aiming to enhance near vision for millions of people. The company remains committed to transforming into a robust commercial organization and looks forward to potential regulatory approval and product launch in the near future.