LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia

Rhea-AI Summary

LENZ Therapeutics (Nasdaq: LENZ) has submitted a New Drug Application (NDA) to the FDA for LNZ100, an aceclidine-based eye drop designed to improve near vision in people with presbyopia. The submission is supported by positive data from the pivotal Phase 3 CLARITY study, which demonstrated statistically significant improvements in near vision without compromising distance vision.

Key highlights:

• Presbyopia affects an estimated 1.8 billion people globally and 128 million in the US
• LNZ100 achieved all primary and secondary near vision improvement endpoints
• The treatment was well-tolerated with no serious treatment-related adverse events
• The FDA has a 60-day filing review period to determine if the NDA is complete and acceptable for review

Positive

• Submission of New Drug Application (NDA) to FDA for LNZ100
• Positive results from Phase 3 CLARITY study supporting NDA submission
• LNZ100 achieved all primary and secondary near vision improvement endpoints
• No serious treatment-related adverse events observed in over 30,000 treatment days
• Potential to be best-in-class pupil-selective and long-acting therapeutic option for presbyopia

Negative

• None.

Medical Research Analyst

The NDA submission for LNZ100 marks a significant milestone in the treatment of presbyopia. The positive Phase 3 CLARITY study results demonstrate LNZ100's potential as a best-in-class therapy. Key points:

• Achieved all primary and secondary near vision improvement endpoints
• Statistically significant three-lines or greater improvement in BCDVA at near
• No loss in distance visual acuity
• Well-tolerated with no serious treatment-related adverse events

If approved, LNZ100 could address a vast market of 1.8 billion people globally, including 128 million in the US. The pupil-selective and long-acting properties of LNZ100 could provide a competitive edge in the presbyopia treatment landscape.

Financial Analyst

LENZ Therapeutics' NDA submission for LNZ100 is a pivotal development with significant market implications. Key financial considerations:

• Large addressable market: 1.8 billion people globally, 128 million in the US
• Potential first-mover advantage: If approved, LNZ100 could capture substantial market share
• Revenue potential: Success could translate to substantial future earnings
• R&D investment validation: Positive Phase 3 results justify development costs

Investors should monitor the 60-day FDA filing review closely. Approval could significantly boost LENZ's stock value, while rejection might lead to a sharp decline. The company's financial health and ability to commercialize LNZ100 effectively will be important factors to watch.

Market Research Analyst

The presbyopia treatment market is poised for disruption with LENZ's LNZ100. Key market insights:

• Unmet need: Current treatments often compromise distance vision or have short duration
• Competitive landscape: LNZ100's pupil-selective, long-acting properties could differentiate it
• Market size: 1.8 billion global, 128 million US patients indicate massive potential
• Patient preference: Non-invasive eye drop solution likely to be favored over surgical options

If approved, LNZ100 could rapidly gain market share. However, successful commercialization will depend on pricing strategy, reimbursement policies and effective marketing to both healthcare providers and patients. The company's ability to scale production and distribution will be important for capitalizing on this opportunity.

SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.

“The submission of our NDA for LNZ100 is a significant milestone for LENZ and is a testament to the tremendous focus, execution and collaboration of our team,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “We believe LNZ100 has the potential to be best-in-class as a pupil-selective and long-acting therapeutic option for the treatment of presbyopia. We look forward to working alongside the FDA through this review process.”

The NDA submission is supported by positive data from the pivotal Phase 3 CLARITY study of LNZ100 for the treatment of presbyopia. In the Phase 3 CLARITY study LNZ100 achieved all primary and secondary near vision improvement endpoints with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, without losing one line or more in distance visual acuity, demonstrating LNZ100 was well tolerated with no serious treatment-related adverse events observed in the over 30,000 treatment days monitored in the CLARITY study.

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.

About LENZ Therapeutics
LENZ Therapeutics is a late clinical-stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day.” LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the review and potential approval of our NDA by FDA for the potential regulatory approval and commercialization of LNZ100, if approved; the size of the market opportunity for LNZ100; the beneficial characteristics of LNZ100 and its expected impact on presbyopes; and expectations regarding shareholder value creation. These statements are based on numerous assumptions concerning the development of LENZ’s product candidates and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in our Form 10-Q filed with the SEC on May 8, 2024, and our subsequent filings with the SEC. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Contacts:

Dan Chevallard
LENZ Therapeutics, Inc.
IR@LENZ-Tx.com

FAQ

What is the purpose of LENZ Therapeutics' LNZ100 eye drop?

LNZ100 is an aceclidine-based eye drop developed by LENZ Therapeutics to improve near vision in people with presbyopia, a condition affecting an estimated 1.8 billion people globally.

What were the results of the Phase 3 CLARITY study for LENZ's LNZ100?

The Phase 3 CLARITY study showed that LNZ100 achieved all primary and secondary near vision improvement endpoints, with statistically significant three-lines or greater improvement in near vision without losing distance vision acuity.

When did LENZ Therapeutics (LENZ) submit the New Drug Application for LNZ100?

LENZ Therapeutics announced the submission of the New Drug Application (NDA) for LNZ100 to the U.S. Food and Drug Administration on August 12, 2024.

How long does the FDA have to review LENZ Therapeutics' NDA for LNZ100?

The FDA has a 60-day filing review period to determine whether the NDA submission for LNZ100 is complete and acceptable for review.