Table 1.
Incidence of ocular treatment-emergent adverse events occurring in at least 1% of subjects in the study eye or the treated fellow eye (safety population)
| Adverse events | LBN 0.024% | |
|---|---|---|
| Study eye (N = 130) n (%) | Treated fellow eye (N = 126) n (%) | |
| ≥1 ocular AE | 76 (58.5) | 78 (61.9) |
| ≥1 treatment-related ocular AE | 62 (47.7) | 61 (48.4) |
| Eye disorders | ||
| Conjunctival hyperemiaa | 23 (17.7) | 21 (16.7) |
| Growth of eyelashes | 21 (16.2) | 21 (16.7) |
| Eye irritation | 15 (11.5) | 15 (11.9) |
| Eye pain | 13 (10.0) | 13 (10.3) |
| Iris hyperpigmentation | 5 (3.8) | 5 (4.0) |
| Blepharal pigmentation | 4 (3.1) | 4 (3.2) |
| Blepharitis | 3 (2.3) | 3 (2.4) |
| Eye pruritus | 3 (2.3) | 3 (2.4) |
| Asthenopia | 3 (2.3) | 2 (1.6) |
| Conjunctival hemorrhage | 2 (1.5) | 3 (2.4) |
| Punctate keratitis | 3 (2.3) | 2 (1.6) |
| Trichiasis | 3 (2.3) | 2 (1.6) |
| Cataract | 1 (0.8) | 3 (2.4) |
| Hordeolum | 1 (0.8) | 3 (2.4) |
| Foreign body sensation in eyes | 2 (1.5) | 1 (0.8) |
| Visual impairment | 1 (0.8) | 2 (1.6) |
| Vitreous floaters | 1 (0.8) | 2 (1.6) |
| Chalazion | 0 (0.0) | 2 (1.6) |
Treatment-related ocular AEs were those categorized as possibly, probably, or definitely related to treatment
AE treatment-emergent adverse event, LBN latanoprostene bunod
aReported as an AE (see Table 2 for investigator assessments of hyperemia)