FDA Accepts NDA for LENZ Therapeutics' LNZ100 for Presbyopia Treatment

Key Insights

• The FDA has accepted LENZ Therapeutics' NDA for LNZ100, an aceclidine-based eye drop, for treating presbyopia, which affects 128 million Americans.
• The FDA has set a PDUFA target action date of August 8, 2025, for LNZ100, indicating a potential approval timeline for the novel therapy.
• LNZ100, designed for once-daily use, has shown promise in improving near vision and is supported by positive Phase 3 CLARITY study results.

LENZ Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for LNZ100, an aceclidine-based eye drop, for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100.

This acceptance marks a significant step toward potentially providing a new treatment option for the 128 million people in the United States affected by presbyopia, a condition characterized by the gradual loss of near vision. Globally, an estimated 1.8 billion people are impacted by this condition.

Clinical Support and Development

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 currently not approved for presbyopia treatment in any country. LNZ100 is designed as a preservative-free, single-use, once-daily eye drop.

Eef Schimmelpennink, President and CEO 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."

Commercialization Plans

LENZ Therapeutics is actively preparing for the potential commercial launch of LNZ100. Shawn Olsson, Chief Commercial Officer, noted, "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."

The FDA has indicated that it is not planning to hold an advisory committee meeting to discuss this application.