Table 3.
Treatment-emergent adverse events in study eyes after single bimatoprost implant 10 µg administration by time of onset or worsening (within 2 days or more than 2 days after administration)
| TEAE | Pooled phase 3 ARTEMIS studiesa | Phase 1/2 studyb | ||||
|---|---|---|---|---|---|---|
| Number of patients (%) | Number of patients (%) | |||||
| Within 2 dc | > 2 d | Within 2 dc | > 2 d | |||
| Bimatoprost implant (n = 372) | Topical timolol BID (n = 370) | Bimatoprost implant (n = 372) | Topical timolol BID (n = 370) | Bimatoprost implant (n = 21) | Bimatoprost implant (n = 21) | |
| Any TEAE | 131 (35.2) | 93 (25.1) | 62 (16.7) | 48 (13.0) | 7 (33.3) | 7 (33.3) |
| Conjunctival hyperemia | 66 (17.7) | 40 (10.8) | 19 (5.1) | 11 (3.0) | 2 (9.5) | 1 (4.8) |
| Eye pain | 21 (5.6) | 10 (2.7) | 2 (0.5) | 1 (0.3) | 3 (14.3) | 0 |
| Foreign body sensation | 20 (5.4) | 9 (2.4) | 5 (1.3) | 0 | 3 (14.3) | 0 |
| Eye irritation | 16 (4.3) | 16 (4.3) | 3 (0.8) | 2 (0.5) | 0 | 0 |
| Punctate keratitis | 13 (3.5) | 9 (2.4) | 1 (0.3) | 3 (0.8) | 2 (9.5) | 0 |
| Vision blurred | 13 (3.5) | 7 (1.9) | 1 (0.3) | 1 (0.3) | 1 (4.8) | 1 (4.8) |
| Photophobia | 12 (3.2) | 2 (0.5) | 3 (0.8) | 0 | 2 (9.5) | 1 (4.8) |
| Conjunctival hemorrhage | 11 (3.0) | 13 (3.5) | 0 | 0 | 2 (9.5) | 0 |
| Lacrimation increased | 7 (1.9) | 9 (2.4) | 1 (0.3) | 0 | 3 (14.3) | 1 (4.8) |
| Dry eye | 5 (1.3) | 5 (1.4) | 7 (1.9) | 4 (1.1) | 1 (4.8) | 0 |
| Iritis | 5 (1.3) | 0 | 4 (1.1) | 0 | 0 | 0 |
| Anterior chamber cell | 4 (1.1) | 0 | 2 (0.5) | 0 | 0 | 0 |
| Eyelid edema | 1 (0.3) | 4 (1.1) | 0 | 0 | 0 | 0 |
| Eyelid erythema | 1 (0.3) | 4 (1.1) | 1 (0.3) | 0 | 0 | 0 |
| IOP increased | 0 | 1 (0.3) | 4 (1.1) | 4 (1.1) | 0 | 1 (4.8) |
| Cataract | 0 | 1 (4.8) | ||||
| Chalazion | 0 | 1 (4.8) | ||||
| Conjunctivitis | 0 | 1 (4.8) | ||||
| Cyclitis | 1 (4.8) | 0 | ||||
| Eyelid ptosis | 0 | 1 (4.8) | ||||
| Foreign body in eye | 0 | 1 (4.8) | ||||
| Visual acuity reduced | 1 (4.8) | 1 (4.8) | ||||
| Vitreous detachment | 0 | 1 (4.8) | ||||
BID twice daily, d days, 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 or sham administration (in the timolol BID eyes) are listed
bAll study eye TEAEs reported after a single administration of 10-µg bimatoprost implant over a mean follow-up of 15.3 months are listed
cTEAEs with onset or worsening within 2 days after the day 1 administration of implant or the sham procedure