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

Felipe A Medeiros; Arsham Sheybani; Manjool M Shah; Marcos Rivas; Zhanying Bai; Erica Werts; Iqbal I K Ahmed; E Randy Craven

doi:10.1007/s40123-022-00527-6

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

Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.

Authors

Felipe A Medeiros¹, Arsham Sheybani², Manjool M Shah³, Marcos Rivas⁴, Zhanying Bai⁴, Erica Werts⁴, Iqbal I K Ahmed⁵, E Randy Craven⁴

Affiliations

¹ Department of Ophthalmology, Duke Eye Center, Duke University, 2351 Erwin Rd, Durham, NC, 27705, USA. felipe.medeiros@duke.edu.
² Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, MO, USA.
³ Kellogg Eye Center, Ann Arbor, MI, USA.
⁴ Allergan, an AbbVie Company, Irvine, CA, USA.
⁵ Department of Ophthalmology, University of Toronto, Mississauga, ON, Canada.

Abstract

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.

Keywords: Adherence; Drug delivery system; Drug implant; Glaucoma; Prostaglandin analog.

Associated data

ClinicalTrials.gov/NCT02247804
ClinicalTrials.gov/NCT02250651
ClinicalTrials.gov/NCT01157364