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

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.