Investing.com -- LENZ Therapeutics (NASDAQ:LENZ) stock tumbled 25% on heavy volume Friday in New York after a case of retinal tear associated with its VIZZ eye drop appeared in the FDA’s adverse event reporting system (FAERS).
The eye-drug developer faced significant selling pressure as investors grew concerned about potential safety issues with the company’s presbyopia treatment. TD Cowen noted that safety concerns related to retinal detachment risk had previously impacted the launch of a competing product, Vuity.
According to details provided by management, the patient who experienced the retinal tear had a history of retinal disease, including previously treated bilateral lattice retinal degeneration and a prior retinal tear. The patient had been using VIZZ for multiple days and noticed vision changes on a day when the medication wasn’t used. The patient was diagnosed with a retinal tear in the right eye, received laser treatment, and is reportedly recovering well.
TD Cowen analyst Stacy Ku indicated that this case represents one incident following at least 5,000 VIZZ prescriptions through October, suggesting an incidence rate of 0.01-0.02%. This aligns with LENZ’s guidance for retinal tears of 26 per 100,000 per year.
Key opinion leaders (KOLs) consulted by TD Cowen had previously emphasized the importance of conducting retinal exams before prescribing VIZZ, particularly for high-risk patients. These specialists had also indicated that while VIZZ’s mechanism of action might confer lower risk than Vuity, some incidence of retinal issues was expected given the natural occurrence rate in the presbyopia population.
Investors will likely monitor prescription growth data to gauge whether this safety concern impacts VIZZ’s commercial trajectory, particularly following the planned direct-to-consumer marketing campaign in the first quarter.
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