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Home > Safety Information > Post-marketing data

Post-marketing data in patients with wet AMD

The rates below include cases reported from date of Beovu approval (October 2019) through June 03, 2022.* These events have been reported in Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia,  Czech Republic, Estonia, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordon, Korea, Kuwait, Lebanon, Macao, Malaysia, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, the United Arab Emirates, the United Kingdom and the USA.

Adverse event

Post-marketing adverse event rates in patients with wet AMD
(per 10,000 injections)

Retinal vasculitis

5.5 per 10,000 injections

Retinal vascular occlusion

3.0 per 10,000 injections

Retinal vasculitis + retinal vascular occlusion

5.9 per 10,000 injections

Total of three events of interest

14.3 per 10,000 injections

    Vision loss for total of three events of interest§ 

4.2 per 10,000 injections

*Spontaneous post-marketing reporting systems have several limitations, which can include under-reporting, incompletely documented cases and cases without imaging information

Event rates are discrete; there is no duplication between categories

The term “retinal vascular occlusion” includes physician reports of ocular and retinal infarction and ischemia, retinal vascular (artery and vein) occlusion, stenosis, thrombosis, and embolism.

§The term vision loss includes physician reports of blindness, blindness unilateral, blindness transient or central vision loss