Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension

William C Christie; Mahdi M Basha; Quoc Ho; Kimmie Kim; E Randy Craven; Miriam Kolko

doi:10.2147/OPTH.S427976

Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension

Clin Ophthalmol. 2023 Oct 12:17:3023-3036. doi: 10.2147/OPTH.S427976. eCollection 2023.

Authors

William C Christie¹, Mahdi M Basha², Quoc Ho³, Kimmie Kim³, E Randy Craven³, Miriam Kolko^{4

5}

Affiliations

¹ Scott & Christie Eyecare Associates, Pittsburgh, PA, USA.
² Fraser Eye Care Center, Warren, MI, USA.
³ Allergan, an AbbVie company, Irvine, CA, USA.
⁴ Rigshospitalet, Copenhagen University Hospital, Glostrup, Denmark.
⁵ University of Copenhagen, Copenhagen, Denmark.

Abstract

Purpose: We evaluate the safety and intraocular pressure (IOP)-lowering effect of 15-µg bimatoprost implant (higher dose than the currently approved product) compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma or ocular hypertension.

Methods: Randomized, phase 3, 12-month, multicenter, paired-eye, patient- and efficacy evaluator-masked noninferiority study. Patients with inadequate IOP control were randomized to receive 360° SLT (day 1) or up to 3 administrations of 15-µg bimatoprost implant (day 4, weeks 16 and 32) in the primary eye and the alternative treatment in the contralateral eye. The primary endpoint was IOP change from baseline at weeks 4, 12, and 24.

Results: At weeks 4, 12, and 24, mean IOP change from baseline ranged from -7.01 to -6.65 mm Hg in implant-treated eyes (N=138) and -6.45 to -6.26 mm Hg in SLT-treated eyes (N=138). Differences in IOP change from baseline ranged from -0.70 to -0.25 mm Hg favoring implant; the upper limit of the 95% confidence interval of the difference (implant minus SLT) was <1.0 mm Hg at all 3 visits. The probability of requiring no additional (rescue) IOP-lowering treatment in implant-treated versus SLT-treated eyes was 93.6% versus 86.5% at day 180 and 74.6% versus 77.1% at day 360. Corneal endothelial cell loss was more common in implant-treated eyes and typically occurred after repeated implant administration.

Conclusion: Bimatoprost implant 15 µg met prespecified criteria for statistical and clinical noninferiority to SLT in lowering IOP, and after 1, 2, or 3 administrations, demonstrated a duration of IOP lowering similar to SLT. Bimatoprost implant 15 µg was associated with corneal adverse events in some patients, especially after repeated administrations at a fixed interval, and has been discontinued from development. A lower dose strength of implant (bimatoprost implant 10 µg, Durysta) is US Food and Drug Administration-approved for single administration.

Keywords: clinical trial; drug delivery device; intracameral; paired eye.

Publication types

Case Reports
Clinical Trial

Grants and funding

This study was sponsored by Allergan (an AbbVie company), Irvine, CA, USA. Allergan/AbbVie participated in the design of the study, data management, data analysis, interpretation of the data, and preparation, review, and approval of the manuscript.