Yesafili Adverse Reactions

Summary of the Safety Profile: A total of 3102 patients constituted the safety population in the eight phase III studies. Among those, 2501 patients were treated with the recommended dose of 2 mg.
Serious ocular adverse reactions in the study eye related to the injection procedure have occurred in less than 1 in 1900 intravitreal injections with aflibercept and included blindness, endophthalmitis, retinal detachment, cataract traumatic, cataract, vitreous haemorrhage, vitreous detachment, and intraocular pressure increased (see Precautions).
The most frequently observed adverse reactions (in at least 5% of patients treated with aflibercept) were conjunctival haemorrhage, retinal haemorrhage, visual acuity reduced, eye pain, cataract, intraocular pressure increased, vitreous detachment, and vitreous floaters.
Tabulated List of Adverse Reactions: The safety data described below include all adverse reactions from the eight phase III studies in the indications wet AMD, CRVO, BRVO, DME and myopic CNV with a reasonable possibility of causality to the injection procedure or medicinal product.
The adverse reactions are listed by system organ class and 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 <1/1000). Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. (See Table 8.)

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Description of Selected Adverse Reactions: In the wet AMD phase III studies; there was an increased incidence of conjunctival haemorrhage in patients receiving anti-thrombotic agents. This increased incidence was comparable between patients treated with ranibizumab and aflibercept.
Arterial Thromboembolic Events: Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition. 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 aflibercept clinical trials in patients with AMD, DME, RVO and myopic CNV. Across indications no notable difference between the groups treated with aflibercept and the respective comparator groups were observed.
As with all therapeutic proteins, there is a potential for immunogenicity with Yesafili.