Cases of severe vision loss, inflammation, and potential retinal vasculitis following treatment with Beovu (brolucizumab) injection are currently being investigated by the product’s manufacturer Novartis.

In October 2019, the Food and Drug Administration (FDA) approved Beovu injection, a human vascular endothelial growth factor (VEGF) inhibitor that is administered via intravitreal injection, for the treatment of wet age-related macular degeneration (wet AMD). In clinical trials, the most common adverse events associated with the therapy were blurred vision, cataract, conjunctival hemorrhage, vitreous floaters and eye pain, while intraocular inflammation and retinal artery occlusion were reported in 4% and 1% of patients, respectively. 

To investigate these adverse events, the Company is conducting a comprehensive product quality review and is collecting clinical data related to these cases from the reporting physicians and retina specialists. Most adverse events (ie, blurry vision or increase in floaters) presented within 1 to 2 weeks of treatment initiation after the first or second Beovu injection. Based on these observations, patients should be advised to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, painful or if there is a change in vision in the days following Beovu administration.

Moreover, treatment should be withheld if patients report clinical signs of intraocular inflammation or changes in vision after Beovu injection; appropriate diagnostic evaluation should be performed and symptoms should be treated as clinically indicated.

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Any observed or suspected adverse events should be reported to Novartis at report.novartis.com or (888) 669-6682.

For more information visit novartis.com.