Table 3.
List of ocular and systemic adverse events in patients receiving intravitreal Ranibizumab biosimilar injections
| Adverse event | Frequency (%) |
|---|---|
| Total (number of events/total number of injections [9406]) | 1978 (21.03) |
| nsAE (number of events/total number of injections [9406]) | |
| Subconjunctival hemorrhage | 772 (8.2) |
| Mild ocular pain | 497 (5.27) |
| Total | 1269 (13.49) |
| nsADR (number of events/total number of injections [9406]) | |
| Transient blurring of vision | 612 (6.5) |
| Raised IOP | 31 (0.33) |
| Mild anterior uveitis | 9 (0.1) |
| Total | 652 (6.93) |
| SAE (number of events/total number of injections [9406]) | |
| VH | 5 (0.05) |
| Hyphema | 4 (0.04) |
| Lens injury | 1 (0.01) |
| Total | 10 (0.1) |
| sADR (ocular) (number of events/total number of injections [9406]) | |
| RPE tears | 31 (0.33) |
| Non-infectious vitritis | 2 (0.02) |
| Infectious endophthalmitis | 1 (0.01) |
| Total | 34 (0.36) |
| sADR (systemic) (number of events/total number of patients [6404]) | |
| Non-fatal MI | 7 (0.12) |
| Non-fatal CVA | 6 (0.09) |
| Total | 13 (0.21) |
nsAE non-serious adverse event, nsADR non-serious adverse drug reaction, IOP intraocular pressure, SAE serious adverse event, VH vitreous hemorrhage, sADR serious adverse drug reaction, RPE retinal pigment epithelium, MI myocardial infarction, CVA cerebrovascular accident