Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China

Abstract

Background: To report the clinical outcomes in Chinese patients with primary open-angle glaucoma and ocular hypertension treated with bimatoprost 0.03% therapy.

Methods: Two hundred sixty-three Chinese patients with primary open-angle glaucoma and ocular hypertension who needed initial or additional intraocular pressure (IOP) lowering were recruited in this prospective, open-label, multicenter clinical study and were treated with bimatoprost 0.03%. Patients received bimatoprost 0.03% as initial, replacement or adjunctive IOP-lowering therapy, and follow-up visits were performed at week 1, and month 1 and 3 of the bimatoprost treatment. The efficacy outcome measure was the post-treatment IOP level. The safety outcome measures included the rate of medication-related symptoms, physical signs, reported adverse events, and the level of conjunctival hyperemia.

Results: Among 240 patients who could be categorized by pre-existing therapies and the bimatoprost therapy regimen in the study, IOP values observed in all medication conditions showed significant IOP reduction at all study visits compared with baseline. At 3 months, 8.0 ± 3.7 mmHg (32.0%) reduction in IOP was observed in treatment-naive patients after bimatoprost monotherapy; in the patients previously on various therapy regimens, 1.9 ± 2.8 mmHg (9.5%) to 6.4 ± 6.1 mmHg (24.8%) additional IOP lowering was achieved after switching to bimatoprost monotherapy or bimatoprost combination therapy. The most common adverse event was conjunctival hyperemia, mainly of trace and mild intensity.

Conclusions: Our results show that bimatoprost 0.03% was effective in lowering IOP with favorable safety in Chinese primary open-angle glaucoma and ocular hypertension patients.

Figure 1

Mean IOP of the patients in groups A through E, ITT population. Group A: treatment-naive patients received in-trial bimatoprost monotherapy; Group B: pretrial PG mono-treated patients received in-trial switch monotherapy with bimatoprost; Group C: pretrial non-PG mono- or combination-treated patients received in-trial switch monotherapy with bimatoprost; Group D: pretrial PG combination-treated patients received in-trial PM replacement with bimatoprost; Group E: pretrial non-PG mono- or combination-treated patients received bimatoprost as an adjunctive agent in addition to the previous treatment modality.

Figure 2

Conjunctival hyperemia scoring distribution at each visit. A, Percentage of patients with each grade; B, Percentage of patients with conjunctival hyperemia grade increase from baseline n = 250.