Table 2.
Summary of key AEs up to week 48, safety evaluable population
| Asian country subgroup (n = 120) | Non-Asian country subgroup (n = 1206) | |||
|---|---|---|---|---|
| Faricimab 6 mg (n = 61) |
Aflibercept 2 mg (n = 59) |
Faricimab 6 mg (n = 603) |
Aflibercept 2 mg (n = 603) |
|
| Total number of AEsa | 120 | 88 | 1550 | 1570 |
| Total number of SAEsa | 8 | 5 | 107 | 184 |
| Patients with ≥ 1 ocular AEb | 18 (29.5%) | 15 (25.4%) | 236 (39.1%) | 231 (38.3%) |
| Patients with ≥ 1 ocular SAEb | 1 (1.6%) | 1 (1.7%) | 10 (1.7%) | 12 (2.0%) |
| Patients with ≥ 1 non-ocular AE | 31 (50.8%) | 28 (47.5%) | 315 (52.2%) | 335 (55.6%) |
| Patients with ≥ 1 non-ocular SAE | 6 (9.8%) | 3 (5.1%) | 62 (10.3%) | 79 (13.1%) |
| Patients with ≥ 1 treatment-related ocular AEb | 4 (6.6%) | 2 (3.4%) | 15 (2.5%) | 15 (2.5%) |
| Patients with ≥ 1 treatment-related ocular SAEb | 1 (1.6%) | 0 | 7 (1.2%) | 1 (0.2%) |
| Patients with ≥ 1 ocular AE of special interestb,c | 1 (1.6%) | 1 (1.7%) | 7 (1.2%) | 11 (1.8%) |
| Patients with ≥ 1 AE of IOI (excluding endophthalmitis) b,d | 1 (1.6%) | 0 | 12 (2.0%) | 8 (1.3%) |
| Iridocyclitis | 1 (1.6%) | 0 | 2 (0.3%) | 2 (0.3%) |
| Iritis | 0 | 0 | 3 (0.5%) | 2 (0.3%) |
| Uveitise | 0 | 0 | 2 (0.3%) | 2 (0.3%) |
| Vitritis | 0 | 0 | 3 (0.5%) | 1 (0.2%) |
| Chorioretinitis | 0 | 0 | 1 (0.2%) | 0 |
| Keratic precipitates | 0 | 0 | 1 (0.2%) | 0 |
| Post-procedural inflammation | 0 | 0 | 0 | 1 (0.2%) |
| Patients with ocular SAE known to be associated with anti-VEGFb | ||||
| Endophthalmitis | 0 | 0 | 0 | 1 (0.2%) |
| Rhegmatogenous retinal detachment | 0 | 0 | 0 | 0 |
| Retinal tear | 0 | 0 | 0 | 0 |
| Retinal pigment epithelial tear | 1 (1.6%) | 0 | 3 (0.5%) | 0 |
| Intraocular pressure increased | 0 | 0 | 1 (0.2%) | 0 |
| Traumatic cataract | 0 | 0 | 0 | 0 |
| Retinal vasculitis and retinal occlusive eventsb | ||||
| Retinal vasculitis | 0 | 0 | 0 | 0 |
| Retinal vein occlusion | 0 | 0 | 0 | 0 |
| Retinal artery occlusion | 0 | 0 | 0 | 0 |
| Retinal artery embolism | 0 | 0 | 1 (0.2%)f | 0 |
| Patients with ≥ 1 APTCg event | 0 | 0 | 7 (1.2%) | 6 (1.0%) |
| Death | 0 | 0 | 2 (0.3%) | 3 (0.5%) |
| Non-fatal myocardial infarction | 0 | 0 | 3 (0.5%) | 2 (0.3%) |
| Non-fatal stroke | 0 | 0 | 2 (0.3%) | 1 (0.2%) |
Data are n or n (%)
aTotal number of AEs and SAEs includes non-ocular and ocular events in the study or fellow eye
bOcular AEs and SAEs in the study eye only
cAEs of special interest includes events associated with severe IOI, events that result in a BCVA decrease of 30 letters or more for more than 1 h, or events that require intervention or surgery to prevent permanent vision loss. For frequency counts by Preferred Term, multiple occurrences of the same AE in an individual are counted only once. Includes AEs with onset up to day 349 (last day of week 48 analysis visit window)
dIncludes serious and non-serious IOI events
eSevere IOI events are reported; all other events were mild or moderate
fHollenhorst plaque
gAPTC events were adjudicated by an external committee; all other events were investigator reported
AE adverse event, APTC Antiplatelet Trialists’ Collaboration, BCVA best-corrected visual acuity, IOI intraocular inflammation, SAE serious adverse event, VEGF vascular endothelial growth factor