Purpose:

To evaluate the intraocular pressure (IOP) lowering provided by intracameral administration of a biodegradable, sustained-release bimatoprost implant (10 or 15 µg) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and baseline IOP of ≤25 mmHg or >25 mmHg.

Methods:

In 2 identical, masked, 20-month, phase 3 studies (NCT02247804, n=594; NCT02250651, n=528), patients with OAG or OHT and open anterior angles on gonioscopy were randomized to study eye treatment with 10-µg or 15-µg bimatoprost implant administered intracamerally on Day 1 and Weeks 16 and 32, or topical timolol 0.5% BID. The randomization was stratified by baseline Hour 0 IOP of ≤25 or >25 mmHg. The primary efficacy period was through Week 12. The present analysis evaluated Hour 0 IOP lowering in the 12 weeks after each administration in patients stratified by baseline Hour 0 IOP of ≤25 or >25 mmHg. Pooled data from both completed studies were analyzed.

Results:

Baseline mean (SD) IOP at Hour 0 was comparable among treatment groups: 24.5 (2.6) mmHg in the 10-µg implant group, 24.6 (2.7) mmHg in the 15-µg implant group, and 24.5 (2.6) mmHg in the timolol group. The proportion of patients with ≥20% IOP lowering at Week 12 was 71.4%, 68.8%, and 69.4% for patients with baseline IOP ≤25 mmHg (n=797) and 73.1%, 76.9%, and 72.5% for patients with baseline IOP >25 mmHg (n=325), in the 10-µg implant, 15-µg implant, and timolol groups, respectively. Mean 12-week average Hour 0 IOP reductions from baseline showed efficacy in patients with baseline IOP ≤25 and >25 mmHg in each treatment group after the 1st, 2nd, and 3rd administration.

Conclusions:

Initial and repeat administration of bimatoprost implant effectively lowered IOP in patients with baseline IOP ≤25 and >25 mmHg. In patients with baseline IOP >25 mmHg, the implant demonstrated efficacy comparable to that of a fixed combination of two topical medications, providing 9–10 mmHg average IOP lowering over 12 weeks post-administration.