LENZ Therapeutics (LENZ) rolls out FDA-approved VIZZ eye drop for adult presbyopia

Rhea-AI Filing Summary

LENZ Therapeutics announced that VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop approved in the United States for treating presbyopia in adults, is now available. This medicine is intended to help adults with age-related difficulty focusing on near objects.

LENZ has begun distributing professional product samples nationwide through its sales force to optometrists and ophthalmologists so eye-care professionals can evaluate and introduce VIZZ to patients. Commercial product shipments to consumers will begin in October through an ePharmacy partner and are expected to expand to broad retail pharmacy availability by mid‑Q4 2025.

Positive

• Commercial launch of VIZZ™ for presbyopia: LENZ reports that VIZZ (aceclidine ophthalmic solution) 1.44%, described as the first and only FDA-approved aceclidine-based eye drop for presbyopia in adults, is now available, with sampling underway and broad retail availability anticipated by mid‑Q4 2025.

Negative

• None.

Insights

Biopharma commercialization analyst

LENZ moves its first-in-class presbyopia eye drop from approval into commercial launch.

The company states that VIZZ™ 1.44% is the first and only FDA-approved aceclidine-based eye drop for presbyopia in adults. Moving from approval to availability means LENZ is entering the commercial phase, where physician uptake and patient adoption will drive revenue potential.

Nationwide professional sample distribution to optometrists and ophthalmologists is underway, which can support early clinical experience and prescribing habits. LENZ plans consumer shipments via an ePharmacy in October, with broad retail pharmacy access anticipated by mid‑Q4 2025. Subsequent disclosures may detail prescription volumes, pricing, and early market traction.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 30, 2025

LENZ THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40532

84-4867570

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

201 Lomas Santa Fe Dr., Suite 300
Solana Beach, California						92075
(Address of principal executive offices)						(Zip code)

(858) 925-7000

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.00001 per share

LENZ

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On September 30, 2025, LENZ Therapeutics, Inc. (“LENZ”) issued a press release announcing the availability of VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop approved in the United States by the U.S. Food and Drug Administration (“FDA”) for the treatment of presbyopia in adults. A copy of the press release is furnished herewith as Exhibit 99.1.

The information contained in Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly provided by specific reference in such a filing.

Item 8.01 Other Events.

As set forth above, on September 30, 2025, LENZ announced that VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, is now available. Professional product sample distribution by LENZ's sales force to optometrists and ophthalmologists has been initiated nationwide. Commercial product shipments will be initiated to consumers in October through LENZ's ePharmacy partner and is anticipated to be broadly available, including via retail pharmacies, by mid-Q4 2025.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press Release, dated September 30, 2025.
104						Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: September 30, 2025

LENZ THERAPEUTICS, INC.
By:			/s/ Daniel Chevallard
Name:			Daniel Chevallard
Title:			Chief Financial Officer
			(Principal Financial and Accounting Officer)

FAQ

What did LENZ (LENZ) announce regarding VIZZ for presbyopia?

LENZ announced that VIZZ (aceclidine ophthalmic solution) 1.44% is now available in the United States for adults with presbyopia. The company describes it as the first and only FDA-approved aceclidine-based eye drop for this age-related near-vision condition.

When will VIZZ from LENZ Therapeutics be available in pharmacies?

LENZ expects broad pharmacy availability for VIZZ by mid‑Q4 2025. Consumer shipments are planned to begin in October through the company’s ePharmacy partner, with distribution later expanding to retail pharmacies across the United States during the same quarter.

How is LENZ introducing VIZZ to eye-care professionals?

LENZ has started professional product sample distribution of VIZZ nationwide through its sales force. These samples are being provided to optometrists and ophthalmologists so they can evaluate the treatment in practice and begin offering it to appropriate adult patients with presbyopia.

What condition does LENZ’s VIZZ eye drop treat?

VIZZ is indicated for the treatment of presbyopia in adults, an age-related condition that makes near vision more difficult. LENZ notes that VIZZ is the first and only aceclidine-based eye drop approved by the FDA in the United States for this specific use.

How will consumers initially obtain VIZZ from LENZ Therapeutics?

Consumers will first be able to obtain VIZZ through LENZ’s ePharmacy partner starting in October. After this initial channel launch, the company anticipates that VIZZ will become broadly available via retail pharmacies nationwide by mid‑Q4 2025.