Table 3 Major reported safety data from study patient population over 18 months.
AEs, No. of participants (%) | Avacincaptad pegol 2 mg (n = 67) | Avacincaptad pegol 4 mg (n = 83) | Sham (n = 110) |
---|---|---|---|
Ocular SAEs, study eyea | 1 (1.5) | 1 (1.2) | 0 |
Ocular SAEs, fellow eye | 0 | 0 | 0 |
Ocular TEAEs, study eye | 39 (58.2) | 61 (73.5) | 45 (40.9) |
Ocular TEAEs, fellow eye | 15 (22.4) | 24 (28.9) | 25 (22.7) |
Study drug-related ocular TEAEs, study eye | 0 | 0 | 0 |
Endophthalmitis | 0 | 0 | 0 |
Intraocular inflammationa | 1 | 0 | 0 |
Discontinuation from trial related to study drug | 0 | 0 | 0 |
Systemic SAEs | 11 (16.4) | 20 (24.1) | 28 (25.5) |
Study drug-related systemic SAEs | 0 | 0 | 0 |
Systemic TEAEs | 41 (61.2) | 53 (63.9) | 66 (60.0) |
Study drug-related systemic TEAEs | 0 | 0 | 0 |