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.

PURPOSE: To evaluate the efficacy and safety of preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01%) compared with BAK-preserved bimatoprost ophthalmic solution 0.01% (PB 0.01%) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

METHODS

In two international Phase III, randomized, investigator-masked trials, 951 patients with OAG or OHT and controlled intraocular pressure (IOP) at screening were randomized following washout to receive PFB 0.01% (n=468) or PB 0.01% (n=483) daily for 84 days. The primary endpoint was the mean IOP change from baseline at Weeks 6, and 12 at 8 am, 10 am, and 4 pm. Safety was assessed by monitoring adverse events (AEs), conjunctival hyperemia, corneal fluorescein staining, ocular tolerance, and patient reported symptoms.

RESULTS

PFB 0.01% and PB 0.01% demonstrated similar IOP reductions at all time points (31-35% vs. 32-36%, respectively). Across the 12-week treatment period, between-group differences in IOP lowering were <1.0 mm Hg at all time points. A trend toward fewer patients reporting treatment-related ocular AEs was observed in the PFB 0.01% group compared with the PB 0.01% group (23.8% vs. 27.6%, respectively). Most common events included conjunctival hyperemia and eye irritation. There was a numerical trend in favor of PFB 0.01% in terms of presence of conjunctival hyperemia and CFS at Week 6 and Week 12.

CONCLUSION

This pooled analysis of nearly 1000 patients confirmed the efficacy and safety outcomes observed in the individual Phase III pivotal studies, supporting the clinical use of preservative-free bimatoprost 0.01% in the management of glaucoma and OHT.