TABLE 4.
Common eye-related adverse events (≥2% and by >1 subject in any treatment group), by severity and length of bimatoprost 0.03% exposure in the six pooled studies
| ADVERSE EVENT | SEVERITY OF ADVERSE EVENTS | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild, n (%) | Moderate, n (%) | Severe,‡ n (%) | ||||||||||
| ≤4 Months* | ≤12 Months† | ≤4 Months* | ≤12 Months† | ≤4 Months* | ≤12 Months† | |||||||
| BIM (n=562) | VEH (n=379) | BIM (n=680) | VEH (n=379) | BIM (n=562) | VEH (n=379) | BIM (n=680) | VEH (n=379) | BIM (n=562) | VEH (n=379) | BIM (n=680) | VEH (n=379) | |
| Conjunctival hyperemia | 30 (5.3) | 5 (1.3) | 41 (6.0) | 5 (1.3) | 0 | 0 | 1 (0.1) | 0 | 1 (0.2) | 0 | 1 (0.1) | 0 |
| Punctate keratitis | 13 (2.3) | 3 (0.8) | 22 (3.2) | 6 (1.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blepharal pigmentation | 14 (2.5) | 1 (0.3) | 20 (2.9) | 2 (0.5) | 2 (0.4) | 0 | 3 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Eyelids-pruritus | 16 (2.8) | 8 (2.1) | 20 (2.9) | 8 (2.1) | 2 (0.4) | 0 | 3 (0.4) | 0 | 0 | 0 | 0 | 0 |
| Erythema of eyelid | 8 (1.4) | 2 (0.5) | 17 (2.5) | 3 (0.8) | 3 (0.5) | 0 | 5 (0.7) | 0 | 0 | 0 | 0 | 0 |
| Eye pruritus | 12 (2.1) | 2 (0.5) | 13 (1.9) | 2 (0.5) | 0 | 1 (0.3) | 1 (0.1) | 1 (0.3) | 1 (0.2) | 0 | 1 (0.1) | 0 |
*
Subjects in Study 5 are not included in the analysis up to four months.
†
Up to six months for vehicle group.
‡
2 additional severe eye-related AEs did not meet cutoff criteria for inclusion in this table: one case each of allergic conjunctivitis and eye irritation
BIM=bimatoprost; VEH=vehicle