Table 4.
Treatment-emergent adverse events in phakic and pseudophakic study eyes after single 10-µg bimatoprost implant administration by time of onset or worsening (pooled ARTEMIS phase 3 study results)
| TEAEa | Number of patients (%) | |||
|---|---|---|---|---|
| Onset or worsening of TEAE within 2 days after administrationb | Onset or worsening of TEAE > 2 days after administration | |||
| Phakic study eyes (n = 285) | Pseudophakic study eyes (n = 87) | Phakic study eyes (n = 285) | Pseudophakic study eyes (n = 87) | |
| Any TEAE | 104 (36.5) | 27 (31.0) | 46 (16.1) | 16 (18.4) |
| Conjunctival hyperemia | 52 (18.2) | 14 (16.1) | 18 (6.3) | 1 (1.1) |
| Eye pain | 16 (5.6) | 5 (5.7) | 2 (0.7) | 0 |
| Foreign body sensation | 16 (5.6) | 4 (4.6) | 3 (1.1) | 2 (2.3) |
| Eye irritation | 15 (5.3) | 1 (1.1) | 3 (1.1) | 0 |
| Punctate keratitis | 8 (2.8) | 5 (5.7) | 1 (0.4) | 0 |
| Vision blurred | 12 (4.2) | 1 (1.1) | 1 (0.4) | 0 |
| Photophobia | 11 (3.9) | 1 (1.1) | 2 (0.7) | 1 (1.1) |
| Conjunctival hemorrhage | 8 (2.8) | 3 (3.4) | 0 | 0 |
| Lacrimation increased | 7 (2.5) | 0 | 1 (0.4) | 0 |
| Dry eye | 4 (1.4) | 1 (1.1) | 6 (2.1) | 1 (1.1) |
| Iritis | 4 (1.4) | 1 (1.1) | 4 (1.4) | 0 |
| Anterior chamber cell | 2 (0.7) | 2 (2.3) | 1 (0.4) | 1 (1.1) |
| IOP increased | 0 | 0 | 2 (0.7) | 2 (2.3) |
IOP intraocular pressure, TEAE treatment-emergent adverse event
aAll study eye TEAEs reported in ≥ 1% of patients up to 16 weeks after a single administration of 10-µg bimatoprost implant are listed
bTEAEs with onset or worsening within 2 days after the day 1 administration of implant