Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension

• Published in: Ophthalmology and therapy Vol. 11; no. 4; pp. 1517 - 1537
• Main Authors: Medeiros, Felipe A., Sheybani, Arsham, Shah, Manjool M., Rivas, Marcos, Bai, Zhanying, Werts, Erica, Ahmed, Iqbal I. K., Craven, E. Randy
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01-08-2022
• Subjects: Internal Medicine; Medicine; Medicine & Public Health; NCT; NCT01157364; NCT02247804; NCT02250651; Ophthalmology; Original Research; Adherence; Glaucoma; Drug delivery system; Prostaglandin analog; Drug implant
• ISSN: 2193-8245; 2193-6528
• DOI: 10.1007/s40123-022-00527-6

Introduction
This study evaluated the intraocular pressure (IOP)-lowering efficacy and safety of a single intracameral administration of bimatoprost implant 10 µg in adults with open-angle glaucoma or ocular hypertension.
Methods
Two identically designed, randomized, 20-month, parallel-group, phase 3 clinical trials (one study eye/patient) compared three administrations of 10- or 15-µg bimatoprost implant (day 1, weeks 16 and 32) with twice-daily topical timolol maleate 0.5%. An open-label, 24-month, phase 1/2 clinical trial compared one or two implants administered in the study eye with once-daily topical bimatoprost 0.03% in the fellow eye. Separate analyses of the pooled phase 3 and phase 1/2 study datasets evaluated outcomes in the 10-µg bimatoprost implant and comparator treatment arms after a single implant administration, up to the time of implant re-administration or rescue with IOP-lowering medication.
Results
In the phase 3 studies, 10-µg bimatoprost implant single administration demonstrated IOP reductions (hour 0) of 4.9–7.0 mmHg through week 15 from a mean (standard deviation, SD) baseline IOP of 24.5 (2.6) mmHg (
n
 = 374); IOP in the topical timolol BID group was reduced by 6.0–6.3 mmHg from a mean (SD) baseline IOP of 24.5 (2.6) mmHg (
n
 = 373). In the phase 1/2 study (
n
 = 21), median time to use of additional IOP-lowering treatment (Kaplan–Meier analysis) was 273 days (approximately 9 months), and 5 of 21 enrolled patients (23.8%) required no additional IOP-lowering treatment up to 24 months after single administration. In each study, after a single implant administration there were no reports of corneal edema, corneal endothelial cell loss, or corneal touch, and no patients had 20% or greater loss in corneal endothelial cell density.
Conclusions
Bimatoprost implant single administration lowers IOP and has a favorable safety profile. Additional studies are needed to further evaluate the duration of effect and factors predicting long-term IOP lowering after a single implant administration.
Trial registration numbers
ClinicalTrials.gov NCT02247804, NCT02250651, and NCT01157364.