US FDA accepts NDA for LENZ Therapeutics' LNZ100 for the treatment of presbyopia

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The US FDA has accepted LENZ Therapeutics’ New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, according to the company in a news release.¹ The NDA submission is supported by positive data results from the pivotal Phase 3 CLARITY study, released in April 2024, which reached all primary and secondary near vision improvement endpoints with participants reaching 3-lines or greater improvement in Best Corrected Distance Visual Acuity at near and did not lose 1 line or more in distance visual acuity.^1,2

“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,” said Eef Schimmelpennink, president and CEO of LENZ Therapeutics, in the release. “Since our public debut in March 2024, we have generated tremendous momentum and demonstrated consistent clinical, regulatory and financial execution, and are focused on transforming LENZ into a robust commercial organization in anticipation of a potential launch as early as the second half of 2025.”

LENZ Therapeutics had submitted the NDA to the US FDA in August 2024.³ Currently, the FDA is not planning to hold an advisory committee meeting to discuss the application. LENZ Therapeutics has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025.¹

“This is an important milestone as we advance our commercial preparations in anticipation of a potential approval in August 2025,” said Shawn Olsson, LENZ Therapeutics chief commercial officer, in the release. “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.”

Aceclidine a new chemical entity in the US and is not approved for the treatment of presbyopia in any country.¹

References:

1. LENZ Therapeutics announces FDA acceptance of New Drug Application for LNZ100 for the treatment of presbyopia. News release. LENZ Therapeutics. October 21, 2024. Accessed October 24, 2024. https://ir.lenz-tx.com/news-events/press-releases/detail/22/lenz-therapeutics-announces-fda-acceptance-of-new-drug-application-for-lnz100-for-the-treatment-of-presbyopia

2. Joy J. LENZ Therapeutics announces positive results from Phase 3 CLARITY trials. Optometry Times. April 10, 2024. Accessed October 24, 2024. https://www.optometrytimes.com/view/lenz-therapeutics-announces-positive-results-from-phase-3-clarity-trials

3. Joy J. LENZ Therapeutics submits NDA for LNZ100 for the treatment of presbyopia. Optometry Times. August 12, 2024. Accessed October 24, 2024. https://www.optometrytimes.com/view/lenz-therapeutics-submits-nda-for-lnz100-for-the-treatment-of-presbyopia