Preservative-free bimatoprost 0.01% ophthalmic gel provided intraocular pressure (IOP) lowering comparable to BAK-preserved bimatoprost 0.01% solution in patients with open-angle glaucoma or ocular hypertension, according to a pooled analysis of two Phase 3 trials.
The analysis included 951 patients with controlled IOP at screening who were randomized after washout to receive either preservative-free bimatoprost 0.01% (n = 468) or preserved bimatoprost 0.01% (n = 483 ) once daily for 84 days. Investigators assessed mean IOP change from 8 am, 10 am, and 4 pm at baseline, week 6, and week 12.
Both treatments produced similar reductions in IOP across all time points. Preservative-free bimatoprost achieved reductions of 31% to 35% compared with 32% to 36% for the preserved formulation. Differences in IOP lowering between groups remained under 1.0 mm Hg throughout the 12-week treatment period.
There were fewer treatment-related ocular adverse events in the preservative-free group compared with the preserved group (23.8% vs 27.6%). The most common adverse events were conjunctival hyperemia and eye irritation. Investigators also noted numerical trends favoring the preservative-free formulation for conjunctival hyperemia and corneal fluorescein staining at both weeks 6 and 12.
Reference
Bacharach J, Miller-Ellis E, Harasymowycz P, et al. Efficacy and Safety of Preservative-Free Bimatoprost 0.01% Gel in Patients with Open-Angle Glaucoma and Ocular Hypertension: Results from Two Phase III Randomized Trials. Clin Ophthalmol. 2026;20:571715. doi: 10.2147/OPTH.S571715. PMID: 42004641; PMCID: PMC13086034.
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