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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.

2 mg safety profile
  • 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

    • 1
       Bayer. Data on file (EYLO026).
    • 2
       Bayer. Data on file (EYLO027).
    • 3
      EYLEA® 40 mg/mL Summary of Product Characteristics.