Company: LENZ
Filing Date: 2025-12-12
Form Type: 8-K
Source: 0001815776-25-000077
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Company: LENZ Therapeutics, Inc.
Filing Date: 2025-12-12
Form: 8-K
Item: Item 8.01
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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)