Vabysmo Adverse Reactions

Clinical Trials: Summary of the safety profile: A total of 3,213 patients constituted the safety population in the four Phase III clinical studies (1,926 VABYSMO treated patients; 664 in nAMD and 1,262 in DME).
The most serious adverse reactions were uveitis (0.5%), endophthalmitis (0.3%), vitritis (0.3%), retinal tear (0.2%), and rhegmatogenous retinal detachment (< 0.1%).
The most frequently reported adverse reactions in patients treated with VABYSMO were cataract (11%), conjunctival hemorrhage (7%), IOP increased (4%), vitreous floaters (4%), eye pain (3%) and retinal pigment epithelial tear (nAMD only) (3%).
Tabulated summary of adverse drug reactions from clinical trials: The safety data described as follows include all adverse reactions from the pooled data across four Phase III clinical studies in the indications nAMD and DME, with a reasonable possibility of causality attribution to the injection procedure or medicinal product.
The adverse reactions are listed according to the MedDRA system organ class and ranked by frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000). (See Table 4.)

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Description of selected adverse drug reactions from clinical trials: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. A low incidence rate of arterial thromboembolic events was observed in the VABYSMO clinical trials in patients with nAMD and DME. Across indications no notable difference between the groups treated with VABYSMO and the comparator were observed.
Postmarketing Experience: Not applicable.