Main finding: The bimatoprost implant at two dose strengths (10- and 15-μg) was noninferior to timolol in lowering intraocular pressure at 12 weeks in patients with open angle glaucoma/ocular hypertension.
Purpose: To evaluate safety and efficacy of bimatoprost implant in patients with open angle glaucoma/ocular hypertension
Study type: Randomized controlled trial
Condition: Open angle glaucoma, Ocular Hypertension
Participants: ≥18 years old with Open-angle glaucoma (OAG) or ocular hypertension (OHT)
-open angle inferiorly
-baseline IOP 22-32mmHg
n=594 patients
Intervention:
Group 1: Bimatoprost implant 10 μg
Group 2: Bimatoprost implant 15 μg
Group 3: Timolol bd
Bimatoprost implant administration was repeated twice at 16-week intervals.
Both dose strengths (10- and 15-μg) of bimatoprost implant were noninferior to timolol in IOP lowering after each administration.
The incidence of corneal and inflammatory treatment-emergent adverse events of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol, and highest with the 15-μg dose strength.
Outcomes
Bimatoprost implant 10-μg
Bimatoprost implant 15-μg
Timolol
Mean baseline IOP
24.0
24.2
23.9
Mean IOP at week 12
16.5-17.2
16.5-17.0
17.1-17.5
≥20% corneal endothelial cell density loss at month 20
10.2%
21.8%
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