Ocular TEAEs occurring in ≥2% of subjects in any treatment group
| System/organ class preferred term | LBN 0.006% (n=82) | LBN 0.012% (n=84) | LBN 0.024% (n=83) | LBN 0.040% (n=81) | Latanoprost 0.005% (n=82) |
|---|---|---|---|---|---|
| No of subjects with ≥1 TEAE | 20 (24.4) | 18 (21.4) | 20 (24.1) | 23 (28.4) | 10 (12.2) |
| No of subjects with ≥1 treatment-related TEAE | 17 (20.7) | 18 (21.4) | 16 (19.3) | 19 (23.5) | 10 (12.2) |
| Eye disorders | |||||
| Ocular hyperaemia | 1 (1.2) | 5 (6.0) | 2 (2.4) | 4 (4.9) | 7 (8.5) |
| Conjunctival hyperaemia | 1 (1.2) | 3 (3.6) | 4 (4.8) | 3 (3.7) | 0 |
| Eye irritation | 1 (1.2) | 2 (2.4) | 3 (3.6) | 5 (6.2) | 0 |
| Punctate keratitis | 1 (1.2) | 1 (1.2) | 2 (2.4) | 2 (2.5) | 1 (1.2) |
| Dry eye | 1 (1.2) | 0 | 2 (2.4) | 0 | 0 |
| Abnormal sensation in eye | 2 (2.4) | 0 | 0 | 0 | 0 |
| Eye pain | 0 | 0 | 0 | 2 (2.5) | 0 |
| Photophobia | 0 | 0 | 2 (2.4) | 0 | 0 |
| Administration site conditions | |||||
| Instillation site pain | 12 (14.6) | 14 (16.7) | 10 (12) | 14 (17.3) | 5 (6.1) |
| Instillation site pruritus | 0 | 0 | 0 | 2 (2.5) | 0 |
AEs coded with MedDRA V.13.0.
TEAEs were defined as AEs occurring on or after the first dose date. Treatment-related AEs were defined as possibly, probably or definitely related.AE, adverse event; LBN, latanoprostene bunod; TEAE, treatment-emergent adverse event.