Beovu® (brolucizumab): Updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion.

Summary

• Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion may occur following the first intravitreal injection with Beovu® and at any time of treatment. These events were observed more frequently early on during treatment.
• More intraocular inflammation events were seen among patients who developed anti-brolucizumab antibodies during treatment. Retinal vasculitis and/or retinal vascular occlusion are immune-mediated events. 
• In patients developing intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, treatment with Beovu® should be discontinued and the events should be promptly managed.
• Maintenance doses of Beovu® (after the first 3 doses) should not be administered at intervals less than 8 weeks. This is based on findings from the MERLIN study (see further details in the Background section below).
• Patients with a medical history of intraocular inflammation and/or retinal vascular occlusion in the year prior to treatment with Beovu® are at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored.
• Female sex has been identified as an additional risk factor. A higher incidence was also observed in Japanese patients.
• Patients should be instructed in how to recognise early signs and symptoms of intraocular inflammation, retinal vasculitis and retinal vascular occlusion and be advised to seek medical attention without delay, if these side effects are suspected.