The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section of the labeling:
- Endophthalmitis and retinal detachments
- Increased intraocular pressure
- Thromboembolic events
The most common adverse reactions ( ≥ 5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections with EYLEA including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice.
A total of 2042 patients treated with EYLEA constituted the safety population in four phase 3 studies. Among those, 1441 patients were treated with the recommended dose of 2 mg.
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The data described below reflect exposure to EYLEA in 1824 patients with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, active-controlled clinical studies (VIEW1 and VIEW2) for 12 months [see Clinical Studies].
Table 1: Most Common Adverse Reactions ( ≥ 1%) in Wet AMD Studies
|Active Control (ranibizumab)
|Intraocular pressure increased||5%||7%|
|Detachment of the retinal pigment epithelium||3%||3%|
|Injection site pain||3%||3%|
|Foreign body sensation in eyes||3%||4%|
|Retinal pigment epithelium tear||2%||1%|
|Injection site hemorrhage||1%||2%|
Less common serious adverse reactions reported in < 1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, and endophthalmitis.
Macular Edema Following Central Retinal Vein Occlusion (CRVO)
The data described below reflect exposure to EYLEA in 218 patients with macular edema following CRVO treated with 2 mg dose in 2 double-masked, controlled clinical studies (GALILEO and COPERNICUS) for 6 months [see Clinical Studies].
Table 2: Most Common Adverse Reactions ( ≥ 1%) in CRVO Studies
|Intraocular pressure increased||8%||6%|
|Foreign body sensation in eyes||3%||5%|
|Injection site pain||3%||1%|
|Vision blurred||1%||< 1%|
Less common adverse reactions reported in < 1% of the patients treated with EYLEA were cataract, eyelid edema, corneal edema, retinal tear, hypersensitivity and endophthalmitis.
As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of EYLEA was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to EYLEA in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EYLEA with the incidence of antibodies to other products may be misleading.
In the wet AMD and CRVO studies, the pre-treatment incidence of immunoreactivity to EYLEA was 1% to 3% across treatment groups. After dosing with EYLEA for 52 weeks (wet AMD), or 24 weeks (CRVO), antibodies to EYLEA were detected in a similar percentage range of patients. Both in the wet AMD and in the CRVO studies, there were no differences in efficacy or safety between patients with or without immunoreactivity.