Vabysmo Adverse Reactions

Summary of the safety profile: Based on Phase III studies, the most frequently reported adverse reactions were cataract (10.7%), conjunctival haemorrhage (7.3%), vitreous floaters (3.6%), IOP increased (3.6%), retinal pigment epithelial tear (nAMD only) (2.9%), and eye pain (2.5%).
The most serious adverse reactions were cataract (0.9%), uveitis (0.5%), vitritis (0.3%), endophthalmitis (0.3%), retinal tear (0.2%), rhegmatogenous retinal detachment (<0.1%) (see Precautions).
Tabulated list of adverse reactions: 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). Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. (See Table 4.)

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Description of selected adverse reactions: Product-class-related adverse reactions: 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 DMO. Across indications, no notable difference between the groups treated with Vabysmo and the comparator were observed.
Immunogenicity: There is a potential for an immune response in patients treated with Vabysmo (see Precautions). After dosing with Vabysmo for up to 48 (nAMD) and 100 (DMO) weeks, treatment-emergent anti-faricimab antibodies were detected in approximately 10% of patients. The clinical significance of anti-faricimab antibodies on safety is unclear at this time. Among the patients with anti-faricimab antibodies a higher incidence of intraocular inflammation adverse reactions were observed however the overall incidence of anti-faricimab antibody positivity and intraocular inflammation in the entire trial population is approximately 1%. Anti-faricimab antibodies were not associated with an impact on clinical efficacy or systemic pharmacokinetics.
Retinal pigment epithelial tear: Retinal pigment epithelial (RPE) tear is a complication of pigment epithelial detachment (PED) in patients with nAMD. RPE tears are common in nAMD patients with PED, treated with IVT anti-VEGF agents including faricimab. There was a higher rate of RPE tear in the faricimab group (2.9%) compared to aflibercept group (1.4%). The majority of events were mild to moderate, without impact to vision and occurred during the loading phase.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.