Vabysmo Adverse Reactions

Clinical Trials: Summary of the safety profile from clinical studies: The following safety data were derived from actively controlled (aflibercept) phase III studies.
A total of 4,489 patients constituted the safety population in the six phase III clinical studies (2,567 patients treated with Faricimab (Vabysmo); 664 with nAMD, 1,262 with DME and 641 with BRVO and CRVO). The most serious adverse reactions were serious cataracts (0.8%), uveitis (0.5%), endophthalmitis (0.4%), vitritis (0.4%), retinal tears (0.2%), rhegmatogenous retinal detachment (0.1%) and traumatic cataract (<0.1%).
The most frequently reported adverse reactions in patients treated with Faricimab (Vabysmo) were cataracts (10%), conjunctival hemorrhage (7%), vitreous detachment (4%), IOP increased (4%), vitreous opacities (4%), eye pain (3%) and retinal pigment epithelial tear (nAMD only) (3%).
List of adverse reactions: The safety data described as follows include all adverse reactions from the six phase III clinical studies in the indications nAMD, DME, BRVO and CRVO, as well as from post-marketing surveillance, 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) and not known (frequency cannot be estimated from the available data). (See Table 9.)

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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 Faricimab (Vabysmo) clinical trials in patients with nAMD, DME, BRVO and CRVO. Across indications no notable difference between the groups treated with Faricimab (Vabysmo) and the comparator were observed.
Postmarketing Experience: Rare cases of retinal vasculitis and/or retinal occlusive vasculitis have been reported in the postmarketing setting. Retinal vasculitis and retinal occlusive vasculitis have also been reported in patients treated with other IVT therapies.