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

PRCIS

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 with 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.