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Three Cases of Severe Eye Inflammation Occur After Vabysmo Injection, Report Johns Hopkins Retina Specialists


Vision symptoms resolved within a month, the specialists said in their report in JAMA Ophthalmology, but they say that retina specialists need to be aware that ths side effect from Vabysmo (faricimab) is more common that data from clinical trials would indicate.

Illustration depicting intravitreal injection | Image credit: © AngeloSouza   stock.adobe.com

Severe eye inflammation developed in three of their patients treated with intravitreal injections of Vabysmo (faricimab), Johns Hopkins retina specialist reported in today’s JAMA Ophthalmology.

The vision problems the patients experience as a result of the intraocular inflammation resolved with a month, but the corresponding author Neil M. Bressler, M.D., a professor of ophthalmology at Johns Hopkins, and his colleagues said cluster of cases suggest that severe inflammation of the eye “may be more common than anticipated from the published clinical trials with this intravitreal anti-VEGF [vascular endothelial growth factor] agent.”

The three cases represent 1.6% of the 182 Vabysmo injections administered by Johns Hopkins retina specialists at three different locations during the one-month period between Sept. 20, 2023, and Oct. 20, 2023, when the cases occurred. During that same period, 19 Hopkins retina specialists administered 1,223 injections of other anti-VEGF agents, including Eylea (aflibercept), repackaged bevacizumab (sold under the brand name Avastin) and Lucentis (ranibizumab).

Neil M. Bressler, M.D., and his colleagues at Johns Hopkins reported on three cases of severe eye inflammation after injections with Vabysmo (faricimab) in today's JAMA Ophthalmology.

Neil M. Bressler, M.D., and his colleagues at Johns Hopkins reported on three cases of severe eye inflammation after injections with Vabysmo (faricimab) in today's JAMA Ophthalmology.

“No other cases of acute, severe IOI [intraocular inflammation] including no other cases of infectious or noninfectious endophthalmitis following any other intravitreal anti-VEGF injections were reported among these 19 physicians,” wrote Bressler and his colleagues.

Bressler and his colleagues said that these three cases of inflammation appear to be different from the cases of retinal vasculitis that Genentech, Vabysmo’s manufacturer, warned about in a letter to healthcare providers in November 2023.

Two of the injections associated with severe inflammation came from the same lot of Vabysmo, the third came from a different lot. Test for bacterial and fungal infection were negative in these three cases. One patient developed severe inflammation after receiving 15 infections of Vabysmo and another after ten injections. For the third patient, the inflammation developed after the first injection. In all three cases, the inflammation developed three to four days after the injection.

Bressler and his colleagues note that severe inflammation has been reported after intravitreal injection with other agents, and they offer several possible explanations for instances of “sterile” inflammation after the injections. Some patients may develop antibodies to the drugs (antidrug antibodies) injected into the eye. Protein “aggregates” of the treatment drugs may affect the syringes used to inject the drugs so silicone oil gets released and inadvertently injected into the eye, inducing inflammation. It is also possible, they suggest, that the crystallizable antibody portion of some of these drugs could trigger inflammation in the eye, although Vabysmo has a structure that would limit the chances of that occurring.

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