nbsp;0%
Ocular hyperemia 5% 3% 2% 2%
Foreign body sensation in eyes 3% 5% 3% 0%
Vitreous detachment 3% 4% 2% 0%
Lacrimation increased 3% 4% 3% 0%
Injection site pain 3% 1% 1% 0%
Vision blurred 1% <1% 1% 1%
Intraocular inflammation 1% 1% 0% 0%
Cataract <1% 1% 5% 0%
Eyelid edema <1% 1% 1% 0%
Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis.
Diabetic Macular Edema (DME)
The data described below reflect exposure to EYLEA in 578 patients with DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from baseline to week 52 and from baseline to week 100 [see CLINICAL STUDIES (14.4)].
Table 3: Most Common Adverse Reactions (≥1%) in DME Studies
Adverse Reactions Baseline to Week 52 Baseline to Week 100
EYLEA
(N=578) Control
(N=287) EYLEA
(N=578) Control
(N=287)
Conjunctival hemorrhage 28% 17% 31% 21%
Eye pain 9% 6% 11% 9%
Cataract 8% 9% 19% 17%
Vitreous floaters 6% 3% 8% 6%
Corneal epithelium defect 5% 3% 7% 5%
Intraocular pressure increased 5% 3% 9% 5%
Ocular hyperemia 5% 6% 5% 6%
Vitreous detachment 3% 3% 8% 6%
Foreign body sensation in eyes 3% 3% 3% 3%
Lacrimation increased 3% 2% 4% 2%
Vision blurred 2% 2% 3% 4%
Intraocular inflammation 2% <1% 3% 1%
Injection site pain 2% <1% 2% <1%
Eyelid edema <1% 1% 2% 1%
Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema, and injection site hemorrhage.
6.2 Immunogenicity
As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of EYLEA was eva luated 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, RVO, and DME studies, the pre-treatment incidence of immunoreactivity to EYLEA was approximately 1% to 3% across treatment groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were detected in a similar percentage range of patients. There were no differences in efficacy or safety between patients with or without immunoreactivity.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C. Aflibercept produced embryo-fetal toxicity when administered every thre |
