Demonstrated Safety Profile in DME1
The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.1
DME (VISTA and VIVID: results in chart) and DR (PANORAMA: results below chart) Phase 3 Trials: Most Common Adverse Reactions (≥1%)1
| Baseline to 52 Weeks | Baseline to 100 Weeks | |||
| Adverse Reactions | 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
DR Phase 3 PANORAMA Trial
- Safety data observed in 269 patients with nonproliferative diabetic retinopathy (NPDR) through week 52 in the PANORAMA trial were consistent with those seen in the phase 3 VIVID and VISTA clinical trials
- No new safety signals were identified through year 2 in the PANORAMA trial compared with the known safety profile of EYLEA in the DR population2
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