EYLEA® 2 mg: ESTABLISHED SAFETY PROFILE FROM EXTENSIVE CLINICAL EXPERIENCE
3102 patients were studied in the safety population in the eight Phase III studies of EYLEA 2 mg. Among those, 2,501 patients were treated with the recommended dose of 2 mg.
- In these RCTs, serious adverse reactions related to the injection procedure have occurred in fewer than 1 in 1900 intravitreal injections with EYLEA
- The reported post-marketing incidence rate of retinal vasculitis and/or retinal vascular occlusion with EYLEA has been low (0.04 per 10,000 sold vials/PFS as of 19 May 2023)*
Most frequently observed adverse reactions from eight phase III clinical trials
(In at least 5% of patients treated with EYLEA 2 mg)
Adverse event | Frequency (%) | |
|---|---|---|
Conjunctival haemorrhage | 25 | |
Retinal haemorrhage | 11 | |
Reduced visual acuity | 11 | |
Eye pain | 10 | |
Cataract | 8 | |
Increased intraocular pressure | 8 | |
Vitreous detachment | 7 | |
Vitreous floaters | 7 |
EYLEA 2 mg is contraindicated in patients with hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics, active or suspected ocular or periocular infection, or active severe intraocular inflammation.
Comprehensive safety information is provided in section 4.8 of the Summary of Product Characteristics.
Abbreviations
IOI, intraocular inflammation. RCT, randomised controlled trial.
Footnote
*Spontaneous post-marketing reporting systems have several limitations, which can include under-reporting and incompletely documented cases.
PP-EYL-GB-2331 | August 2024