Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• Zolymbus (bimatoprost 0.01% ophthalmic gel) is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
• In patients with glaucoma or ocular hypertension, preservative-free bimatoprost 0.01% gel achieved mean IOP reductions at week 12 of -9.72 ± 2.97 mm Hg (8 am), -9.41 ± 3.03 mm Hg (10 am), and -8.99 ± 3.36 mm Hg (4 pm), compared with preserved bimatoprost 0.01%, which achieved -9.47 ± 3.06 mm Hg (8 am), -9.19 ± 3.12 mm Hg (10 am), and -8.54 ± 3.44 mm Hg (4 pm).
• Noninferiority of preservative-free bimatoprost 0.01% gel relative to preserved bimatoprost 0.01% was demonstrated using a predetermined upper 95% CI margin of 1.5 mm Hg across all time points.
• Effectiveness outcomes were assessed only in patients with glaucoma or ocular hypertension, without subgroup-specific analyses or comparisons to drugs other than the two bimatoprost formulations.
• Conjunctival hyperemia was the most frequently reported adverse event, occurring in 5.5% (13 patients) with preservative-free bimatoprost 0.01% gel and 6.8% (17 patients) with preserved bimatoprost 0.01%.
• Worsening of conjunctival hyperemia was observed at week 6 in 20.1% of patients with preservative-free bimatoprost 0.01% gel versus 29.3% with preserved bimatoprost 0.01%, and at week 12 in 18.3% versus 30.4%, respectively.
• The study population consisted of patients with open-angle glaucoma or ocular hypertension, and the preservative-free formulation (PFB 0.01% gel) was associated with a lower incidence of worsening conjunctival hyperemia compared with the preserved formulation (PB 0.01%).