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Label updates

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved an update of the Beovu product information on July 13, 2020. The approved amendment to the product information reflects the implementation of a safety labeling change for ‘retinal vasculitis’ and 'retinal vascular occlusion’ which have been reported with the use of Beovu.

The Australian Health Authority (TGA) approved an update of the Beovu prescribing information (PI) on June 25, 2020. The Australian PI has been updated to state that retinal vasculitis and/or retinal vascular occlusion have been reported with the use of Beovu. Concomitant intraocular inflammation was reported, but not in all cases. Prior treatment was not reported for all cases, however, some patients had previous intravitreal VEGF inhibitor therapy.

The Swiss Health Authority (Swissmedic) approved an update of the Beovu prescribing information (PI) on June 12, 2020. The Swiss PI has been updated to state that retinal vasculitis and/or retinal vascular occlusion have been reported with the use of Beovu. In most cases intraocular inflammation was also present.

The US Food and Drug Administration (FDA) approved an update to the Beovu prescribing information on June 9, 2020. The update includes characterization of the adverse events, retinal vasculitis and retinal vascular occlusion, as part of the spectrum of intraocular inflammation noted in the original prescribing information.