Table 4.
Study eye treatment-emergent adverse events in 3% or greater of patients in any treatment group (safety population)
| MedDRA SOC PT |
SE-implant (N = 195) | FE-implant (N = 200) | Timolol (N = 194) |
|---|---|---|---|
| n (%) | n (%) | n (%) | |
| Patients with any TEAEs in the study eye | 77 (39.5) | 68 (34.0) | 39 (20.1) |
| Eye disorders | |||
| Cataract | 7 (3.6) | 3 (1.5) | 3 (1.5) |
| Dry eye | 7 (3.6) | 6 (3.0) | 3 (1.5) |
| Iritis | 12 (6.2) | 1 (0.5) | 0 |
| Ocular hyperemia | 5 (2.6) | 9 (4.5) | 0 |
| Punctate keratitis | 3 (1.5) | 6 (3.0) | 5 (2.6) |
| Visual acuity reduced | 9 (4.6) | 2 (1.0) | 1 (0.5) |
| Investigations | |||
| Intraocular pressure increased | 9 (4.6) | 15 (7.5) | 4 (2.1) |
| Nervous system disorders | |||
| Visual field defect | 6 (3.1) | 6 (3.0) | 2 (1.0) |
Adverse events verbatim terms were coded using MedDRA (version 21.0, English) to the appropriate SOC and PT
FE-implant fast-eluting travoprost intracameral implant, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, SE-implant slow-eluting travoprost intracameral implant, SOC system organ class, TEAE treatment-emergent adverse event