TY - JOUR
T1 - Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension
AU - Medeiros, Felipe A.
AU - Sheybani, Arsham
AU - Shah, Manjool M.
AU - Rivas, Marcos
AU - Bai, Zhanying
AU - Werts, Erica
AU - Ahmed, Iqbal I.K.
AU - Craven, E. Randy
N1 - Funding Information:
This study was sponsored by Allergan (prior to its acquisition by AbbVie Inc). The sponsor participated in the study design; data management, analysis, and interpretation; and the preparation, review, and approval of the manuscript. The journal’s Rapid Service Fee was funded by Allergan, an AbbVie company.
Funding Information:
Jasmine Choi, MS (AbbVie Inc) contributed to the statistical analyses for the manuscript under the direction of the authors. The authors thank Mini Balaram and Teresa S. Ignacio (former AbbVie employees) for their contributions to the conception and design of this study. This study was sponsored by Allergan (prior to its acquisition by AbbVie Inc). The sponsor participated in the study design; data management, analysis, and interpretation; and the preparation, review, and approval of the manuscript. The journal’s Rapid Service Fee was funded by Allergan, an AbbVie company. Writing and editorial assistance was provided to the authors by Evidence Scientific Solutions, Inc (Philadelphia, PA) and funded by Allergan, an AbbVie company. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Neither honoraria nor payments were made for authorship. Marcos Rivas developed the overall concept of the study and the study design. All authors participated in the interpretation of the data and the development of the manuscript, including review, revisions, and approval of the final version. Felipe A. Medeiros is a consultant for Aerie Pharmaceuticals, Allergan (an AbbVie company), Annexon, Biogen, Carl Zeiss Meditec, Galimedix, Novartis, Reichert, and Stealth BioTherapeutics; has received research support from Carl Zeiss Meditec, Google, Heidelberg Engineering, and Reichert; and is a founder of NGoggle, Inc. Arsham Sheybani is a consultant for Allergan (an AbbVie company), Ivantis, and Santen.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/8
Y1 - 2022/8
N2 - 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.
AB - 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.
KW - Adherence
KW - Drug delivery system
KW - Drug implant
KW - Glaucoma
KW - Prostaglandin analog
UR - http://www.scopus.com/inward/record.url?scp=85131096316&partnerID=8YFLogxK
U2 - 10.1007/s40123-022-00527-6
DO - 10.1007/s40123-022-00527-6
M3 - Article
C2 - 35643967
AN - SCOPUS:85131096316
SN - 2193-8245
VL - 11
SP - 1517
EP - 1537
JO - Ophthalmology and Therapy
JF - Ophthalmology and Therapy
IS - 4
ER -