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Post-marketing data in patients with wet AMD and DME
The rates below include cases reported from date of Beovu approval (October 2019) through November 25 2022 for nAMD and DME indications.* These events have been reported in Australia, Austria, Belgium, Bosnia & Herzegovina, Brazil, Canada, Columbia, Croatia, Czech Republic, Estonia, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, the United Arab Emirates, the United Kingdom, Uzbekistan and the USA
Adverse event† |
Post-marketing adverse event rates*#in patients with wet AMD and DME (per 10,000 injections) |
|---|---|
|
Retinal vasculitis |
5.6 per 10,000 injections |
|
Retinal vascular occlusion‡ |
3.0 per 10,000 injections |
|
Retinal vasculitis + retinal vascular occlusion† |
5.0 per 10,000 injections |
|
Total of three events of interest |
13.8 per 10,000 injections |
| Vision loss for total of three events of interest§ |
3.83 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
#The estimated reporting rates are based on a conservative approach, as up-to-date cumulative sales data were not available for Canada, APMA (Asia Pacific, Middle East and Africa) and certain countries from Europe
†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