(5.7%), increased lacrimation (5.0%) and ocular hyperemia (5.0%).
Tabulated list of adverse reactions
The safety data described below include all adverse reactions from the wet AMD and/or CRVO phase III studies 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).
Table 1: Adverse drug reactions reported in the wet AMD and CRVO phase III studies
System Organ Class
Very common
Common
Uncommon
Rare
Immune system disorders
Hypersensitivity***
Eye disorders
Conjunctival haemorrhage, Eye pain
Retinal pigment epithelium tear*, Detachment of the retinal pigment epithelium*, Retinal degeneration, Vitreous haemorrhage, Cataract, Cataract nuclear, Cataract subcapsular, Corneal erosion, Corneal abrasion, Intraocular pressure increased, Vision blurred, Vitreous floaters, Corneal oedema, Vitreous detachment, Injection site pain, Foreign body sensation in eyes, Lacrimation increased, Eyelid oedema, Injection site haemorrhage, Conjunctival hyperaemia, Ocular hyperaemia
Endophthalmitis**, Retinal detachment, Retinal tear, Iritis, Iridocyclitis, Cataract cortical, Lenticular opacities, Corneal epithelium defect, Injection site irritation, Abnormal sensation in eye, Eyelid irritation
Anterior chamber flare,
Vitritis
Uveitis, Hypopyon
* Conditions known to be associated with wet AMD. Observed in the wet AMD studies only.
** Culture positive and culture negative endophthalmitis
*** including allergic 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 following intravitreal use of VEGF inhibitors.
ATEs, as defined by Antiplatelet Trialists' Collaboration (APTC) criteria, include nonfatal myocardial infarction, nonfatal stroke, or vascular death (including deaths of unknown cause). The incidence in the phase 3 wet AMD studies (VIEW1 and VIEW2) during the 96 weeks study duration was 3.3% (60 out of 1,824) in the combined group of patients treated with Eylea compared with 3.2% (19 out of 595) in patients treated with ranibizumab (see section 5.1).
The incidence of ATEs in the CRVO studies (GALILEO and COPERNICUS) during the 76/100 weeks study duration was 0.6% (2 out of 317) in patients treated with at least one dose of Eylea compared to 1.4% (2 out of 142) in the group of patients receiving only sham treatment.
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 Yellow Card Sche |
