Phase 3 Studies: Intracameral bimatoprost implant effective in patients with stratified baseline IOP
Results from 2 phase 3 studies demonstrated that initial and repeat administration of bimatoprost implant (Durysta, Allergan) lowered IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) with baseline IOP ≤25 mm Hg and >25 mm Hg. In patients with baseline IOP >25 mm Hg, the implant demonstrated efficacy comparable to that of a fixed combination of 2 topical medications, providing 9-mm Hg to 10-mm Hg average IOP lowering over 12 weeks post-administration, according to a presentation at ASCRS 2021 Annual Meeting.
In the identical, masked, 20-month, phase 3 studies (n = 594; n = 528), patients 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 mm Hg or >25 mm Hg. The primary efficacy period was through Week 12.
Results demonstrated that the baseline mean IOP at Hour 0 was comparable among treatment groups: 24.5 mm Hg in the 10-µg implant group, 24.6 mm Hg in the 15-µg implant group, and 24.5 mm Hg 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 mm Hg (n = 797) and 73.1%, 76.9%, and 72.5% for patients with baseline IOP >25 mm Hg (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 mm Hg and >25 mm Hg in each treatment group after the 1st, 2nd, and 3rd administration.
Weinreb RN. Efficacy of intracameral bimatoprost implant in patients stratified by baseline IOP (≤25 mm Hg or >25 mmHg) in the phase 3 Artemis studies. Presented at: ASCRS 2021 Annual Meeting.