Safety and Efficacy of a Preservative-Free Bimatoprost 0.01% Ophthalmic Gel: Results from a Phase III Controlled Trial.

Precis: Noninferiority on intraocular pressure (IOP)-lowering efficacy was demonstrated for a preservative-free (PF) bimatoprost 0.01% ophthalmic gel compared with a preserved formulation following a 3-month treatment in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Purpose: To compare the safety and IOP-lowering efficacy of a preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) with a preserved bimatoprost 0.01% ophthalmic solution (PB 0.01%) in patients with OAG or OHT.

Methods: This prospective, Phase III, multicenter, randomized, parallel group, investigator-masked, 3-month study, included patients with OAG or OHT, previously treated with monotherapy, who underwent a maximum 7-week washout period. At Day 1, patients were randomized to receive either PFB 0.01% gel (n=232) or PB 0.01% (n=234) dosed once daily from Day 1 to Day 85. The primary efficacy endpoint was the change from baseline in IOP across 9 timepoints (8 am, 10 am, and 4 pm) at weeks 2, 6 and 12. Safety measures included adverse events (AEs) and conjunctival hyperemia.

Results: Change in IOP from baseline was consistent across timepoints and was similar between treatment groups. Noninferiority of PFB 0.01% gel to PB 0.01% on IOP-lowering over a 12-week treatment period was demonstrated based on predetermined noninferiority margins (below 1.5 mm Hg at all timepoints [9/9] and below 1 mm Hg at the majority of time points [6/9]). Tolerability and safety were comparable with fewer treatment-related ocular AEs in the PFB 0.01% gel group compared to the PB 0.01% group (28.1% vs. 34.8%, respectively), and conjunctival hyperemia at Week 2 (54.8% vs. 63.2%, respectively).

Conclusions: PF bimatoprost 0.01% ophthalmic gel was noninferior to the preserved bimatoprost 0.01% ophthalmic solution, with similar safety and tolerability over 3 months.