-Advertisement-
-Advertisement-
Conference Roundup
Glaucoma

Phase 3 Studies: Intracameral bimatoprost implant effective in patients with stratified baseline IOP

Posted on August 18, 2021
Heidelberg Engineering’s technology spotlighted in various scientific presentations and programming at ARVO Annual Meeting

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.

Reference
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.

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-