Akademik Veri Yönetim Sistemi
Diğer, ss.2017-2023, 2021
Objective To evaluate the intraocular pressure (IOP)-lowering efcacy and safety of 10 and 15 µg bimatoprost implant in
patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG
or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost
implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP
change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal
endothelial cell density (CECD).
Results Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering
through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12
in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third
implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were
77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss,
corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after
repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1%
in topical timolol-treated eyes. Visual feld progression (change in the mean deviation from baseline) was reduced in the 10
µg implant group compared with the timolol group.
Conclusions The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met
the primary endpoint and efectively lowered IOP. The majority of patients required no additional treatment for 12 months
after the third administration. The beneft-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other
administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to
improve adherence and reduce treatment burden in glaucoma.
Clinicaltrials.gov Identifer NCT02250651.