LENZ Therapeutics (NASDAQ: LENZ) reports FAERS retinal tear case in VIZZ

Rhea-AI Filing Summary

LENZ Therapeutics described a recently reported retinal tear in a patient using VIZZ (aceclidine ophthalmic solution) 1.44% that was submitted to the FDA’s FAERS database. The company notes that FAERS data alone do not prove a causal relationship, but it reviewed the case under its pharmacovigilance procedures.

The patient had extensive prior retinal problems, including bilateral lattice degeneration, past peripheral laser treatment, and a previous retinal tear, and had not recently undergone a peripheral retinal exam before starting VIZZ. Several days after beginning therapy, on a non-dosing day, the patient noticed vision changes, was diagnosed with a retinal tear, treated with laser retinopexy, and is recovering well. Independent retina specialists highlighted multiple pre-existing risk factors, so any link to VIZZ remains uncertain. Retinal tears naturally occur at about 25 per 100,000 people per year, and this initial report does not change the company’s current safety expectations for VIZZ.

Insights

Biopharma safety and regulatory analyst

LENZ reports a single retinal tear case in a high-risk VIZZ user, with causal link described as uncertain.

LENZ Therapeutics outlines one retinal tear case in a patient treated with VIZZ (aceclidine ophthalmic solution) 1.44% that appeared in the FDA’s FAERS database. The company emphasizes that FAERS reports do not by themselves establish causality and that this case was reviewed through internal pharmacovigilance processes and external retina specialist input.

Details point to substantial baseline retinal risk: bilateral lattice degeneration, prior peripheral laser treatment, and a previous retinal tear, with no recent peripheral retinal exam before therapy. Independent retina specialists cited these factors as making spontaneous retinal events more likely, and the company states that any causal relationship to VIZZ remains uncertain.

The disclosure also notes that retinal tears naturally occur at an estimated 25 per 100,000 individuals per year and that this initial report does not change current safety expectations for VIZZ. As real‑world use expands, isolated retinal events may still be reported, and the company indicates it does not plan to provide this level of case detail for every future report, reserving such detailed discussion for this first instance.

FALSE0001815776Solana BeachCalifornia00018157762025-12-122025-12-12

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): December 12, 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 8.01 Other Events.

LENZ Therapeutics, Inc. (“the Company”) is aware of a recent adverse event report submitted to the U.S. Food and Drug Administration’s (“FDA”) Adverse Event Reporting System (“FAERS”) database describing a retinal tear in a patient using VIZZ™ (aceclidine ophthalmic solution) 1.44%. While FAERS data does not equate to a causal relationship, the Company takes all safety reports seriously and promptly reviewed the case in accordance with our pharmacovigilance procedures.

The patient had a significant history of underlying retinal pathology, including bilateral lattice degeneration, prior peripheral laser treatment, and a previous retinal tear. According to the report, the patient had not undergone a recent peripheral retinal examination before initiating therapy. Several days after starting treatment, but on a non-dosing day, the patient observed a change in vision and was subsequently diagnosed with a retinal tear, and received laser retinopexy. The patient is recovering well.

Independent retina specialists consulted as part of our assessment noted that the patient had multiple pre-existing risk factors that make spontaneous retinal events more likely, and therefore a causal relationship to VIZZ remains uncertain.

Retinal tears occur naturally at an estimated incidence of approximately 25 per 100,000 individuals per year. As VIZZ use continues to expand in real-world settings, isolated retinal events may occur. This initial report, involving a patient with substantial baseline risk, does not alter our current safety expectations for VIZZ.

Going forward, the Company does not expect to provide this level of case detail for each individual report, but felt it was appropriate for this initial instance.

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: December 12, 2025

LENZ THERAPEUTICS, INC.
By:			/s/ Evert Schimmelpennink
Name:			Evert Schimmelpennink
Title:			Chief Executive Officer
			(Principal Executive Officer)

FAQ

What event did LENZ Therapeutics (LENZ) disclose about VIZZ?

LENZ Therapeutics disclosed that a retinal tear in a patient using VIZZ (aceclidine ophthalmic solution) 1.44% was reported to the FDA’s FAERS database.

What happened to the patient using VIZZ in the reported case?

Several days after starting VIZZ, on a non-dosing day, the patient noticed vision changes, was diagnosed with a retinal tear, treated with laser retinopexy, and is recovering well.

What pre-existing retinal conditions did the patient have before using VIZZ?

The patient had bilateral lattice degeneration, prior peripheral laser treatment, and a previous retinal tear, and had not undergone a recent peripheral retinal examination before therapy.

Do LENZ Therapeutics and independent specialists view VIZZ as the confirmed cause of the retinal tear?

Independent retina specialists noted multiple pre-existing risk factors, and LENZ Therapeutics states that a causal relationship to VIZZ remains uncertain.

Does this retinal tear case change LENZ Therapeutics’ safety expectations for VIZZ?

LENZ Therapeutics states that this initial report, in a patient with substantial baseline risk, does not alter its current safety expectations for VIZZ.

What natural incidence rate of retinal tears does LENZ Therapeutics cite?

The company cites that retinal tears occur naturally at an estimated incidence of approximately 25 per 100,000 individuals per year.

Will LENZ Therapeutics provide similar case detail for future VIZZ safety reports?

LENZ Therapeutics states it does not expect to provide this level of case detail for each individual future report, considering this level of detail appropriate for the initial instance.