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.