Eylea Adverse Reactions

Summary of the safety profile: A total of 3,102 patients constituted the safety population in the eight phase III studies. Among those, 2,501 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 1,900 intravitreal injections with Eylea 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 Eylea) were conjunctival haemorrhage (25%), retinal haemorrhage (11%), visual acuity reduced (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8%), vitreous detachment (7%), and vitreous floaters (7%).
114.3 mg/ml vial: Serious adverse reactions were cataract (8.2%), retinal haemorrhage (3.6%), intraocular pressure increased (2.8%), vitreous haemorrhage (1.2%), cataract subcapsular (0.9%), cataract nuclear (0.6%), retinal detachment (0.6%), and retinal tear (0.5%). The most frequently observed adverse reactions in patients treated with Eylea 114.3 mg/ml were cataract (8.2%), visual acuity reduced (4.4%), vitreous floaters (4.0%), conjunctival haemorrhage (3.8%), vitreous detachment (3.7%), retinal haemorrhage (3.6%), intraocular pressure increased (2.8%), and eye pain (2.0%). The safety profile observed in the 3 clinical studies was similar in patients treated with Eylea 114.3 mg/ml (N=1 217) and Eylea 40 mg/ml (N=556), and in patients with nAMD and DME.
Tabulated list of adverse reactions: The safety data described as follows 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 <1/1,000).
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. (See Table 10.)

Click on icon to see table/diagram/image

114.3 mg/ml vial: A total of 1,217 patients treated with Eylea 114.3 mg/ml constituted the safety population in 3 clinical phase II/III studies (CANDELA, PULSAR, PHOTON). The safety data described previously include all adverse reactions with a reasonable possibility of causality to the injection procedure or medicinal product reported. (See Table 11.)

Click on icon to see table/diagram/image

The following adverse reactions of Eylea 40 mg/ml are also considered expected with Eylea 114.3 mg/ml but have not been reported in the clinical studies with Eylea 114.3 mg/ml: abnormal sensation in eye, corneal epithelium defect, anterior chamber flare, endophthalmitis, blindness, traumatic cataract, hypopyon, severe anaphylactic/anaphylactoid reactions.
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 Eylea.
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 Eylea clinical trials in patients with nAMD, 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 Eylea.
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 via the local reporting system.