Study eye, n (%) | CLS-TA 4.0 mg (N=38) |
Total number of ocular adverse events | 41 |
Number of patients with ≥1 ocular AE | 19 (50.0) |
Treatment-related ocular AEs | 7 (18.4) |
Serious ocular AEs | 0 |
Treatment-related serious AEs | 0 |
TEAEs leading to study drug discontinuation | 0 |
Adverse events | |
Cataract* | 4 (10.5) |
Cystoid macular oedema | 0 |
Endophthalmitis | 0 |
Eye pain†: time of procedure | 3 (7.9) |
Eye pain†: any time post procedure | 1 (2.6) |
Elevated IOP‡: time of procedure | 1 (2.6) |
Elevated IOP‡: pertaining to corticosteroid§ | 5 (13.2) |
Retinal detachment | 0 |
Suprachoroidal haemorrhage | 0 |
Worsening of uveitis | 1 (2.6) |
Vitreous detachment | 1 (2.6) |
*Cataract includes the medDRA preferred terms (a) cataract, (b) cataract subcapsular and (c) cataract nuclear.
†‘Eye pain’ includes the preferred terms (a) eye pain and (b) injection site pain.
‡‘Elevated IOP’ includes the preferred terms (a) IOP increased and (b) ocular hypertension.
§Includes all events of elevated IOP that did not occur on the day of the procedure.
AE, adverse event ; CLS-TA, investigational triamcinolone acetonide injectable suspension; IOP, intraocular pressure.