Table 3.
TEAEsa reported by three pivotal trials of LBN
| Number subjects receiving LBN in safety populationb | KRONUS51–53 24 |
VOYAGER54–57 330 |
APOLLO68–71 283 |
Pooled total 637 |
|---|---|---|---|---|
| Ocular TEAEs, N (%) | ||||
| Instillation site pain | 0 | 50 (15.2%) | 3 (1.1%) | 53 (8.3%) |
| Conjunctival hyperemia | 12 (50.0%) | 11 (3.3%) | 8 (2.8%) | 31 (4.9%) |
| Punctate keratitis | 13 (54.2%) | 6 (1.8%) | 0 | 19 (3.0%) |
| Ocular hyperemia | 0 | 12 (3.6%) | 0 | 12 (1.9%) |
| Eye irritation | 0 | 0 | 11 (3.9%) | 11 (1.7%) |
| Eye pain | 1 (4.2%) | 2 (0.6%) | 4 (1.4%) | 7 (1.1%) |
| Dry eye | 0 | 3 (0.9%) | 3 (1.1%) | 6 (0.9%) |
| Abnormal or foreign-body sensation | 0 | 2 (0.6%) | 3 (1.1%) | 5 (0.8%) |
| Instillation site pruritus | 0 | 2 (0.6%) | 0 | 2 (0.3%) |
| Photophobia | 0 | 2 (0.6%) | 0 | 2 (0.3%) |
| Conjunctival disorder, unspecified | 1 (4.2%) | 0 | 0 | 1 (0.2%) |
| Reduced visual acuity | 1 (4.2%) | 0 | 0 | 1 (0.2%) |
| Total subjects with ≥1 ocular TEAE | 21 (87.5%) | 81 (24.5%) | 38 (13.4%) | 140 (22.0%) |
| Nonocular TEAEs, N (%) | ||||
| Headache | 0 | 1 (0.3%) | 2 (0.7%) | 3 (0.5%) |
| Fatigue | 0 | 0 | 1 (0.4%) | 1 (0.2%) |
| Hair color changes | 0 | 0 | 1 (0.4%) | 1 (0.2%) |
| Hair disorder, unspecified | 0 | 0 | 1 (0.4%) | 1 (0.2%) |
| Sinus congestion | 0 | 0 | 1 (0.4%) | 1 (0.2%) |
| Total subjects with ≥1 nonocular TEAE | 0 | 1 (0.3%) | 5 (1.8%) | 6 (0.9%) |
| TEAEs leading to discontinuation of therapy | 0 | 5 (1.5%) | 4 (1.4%) | 9 (1.4%) |
Notes:
Adverse events occurring on or after administration of the first treatment dose during the duration of the study. Includes all ocular TEAEs reported, irrespective of presumed etiology. Nonocular TEAEs include only those considered by the trial authors to be related to LBN treatment. Ocular TEAE data correspond to study eyes, as not all trials reported fellow treated eye TEAE data. Ocular TEAEs were reported if their incidence in the safety population eyes receiving LBN met the following criteria: ≥1% of treatment and fellow eyes combined (APOLLO), ≥2% of any LBN treatment arm (VOYAGER), or any eyes (KRONUS).
Defined as subjects receiving at least one treatment dose. Adapted by permission from BMJ Publishing Group Limited. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Weinreb RN, Ong T, Scassellati Sforzolini B, et al. Br J Ophthalmol. © 2015;99(6):738–745.54 Adapted from Adv Ther, 32, 2015, 1128–1139, Evaluation of the effect of latanoprostene bunod ophthalmic solution, 0.024% in lowering intraocular pressure over 24 h in healthy Japanese subjects Araie M, Sforzolini BS, Vittitow J, Weinreb RN, copyright 2015.51 Data from Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanobunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: the APOLLO Study. Ophthalmology. 2016;123(5):965–973.68
Abbreviations: LBN, latanoprostene bunod; TEAEs, treatment-emergent adverse events.