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

Jason Bacharach,1,2 Eydie Miller-Ellis,3 Paul Harasymowycz,4,5 James H Peace,6 Sylvie Nissle,7 Douglas G Day,8 Ingeborg Stalmans9,10 1North Bay Eye Associates Inc, Sonoma County, CA, USA; 2Department of Ophthalmology, California Pacific Medical Center, Pacific Vision Eye Institute, San Francisco, CA, USA; 3Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 4University of Montreal, Montreal, QC, Canada; 5Bellevue Ophthalmology Clinics and Montreal Glaucoma Institute, Montreal, QC, Canada; 6United Medical Research Institute, Inglewood, CA, USA; 7Laboratoires Thea, Clermont-Ferrand, 63000, France; 8Coastal Research Associates. Coastal Research Associates, Roswell, GA, USA; 9Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium; 10Research Group of Ophthalmology, Catholic University KU Leuven, Leuven, BelgiumCorrespondence: Jason Bacharach, North Bay Eye Associates, 35 Maple St, Sonoma, CA, 95476, USA, Tel +1 707-996-1052, Fax +1 707-762-6873, Email [email protected]: 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.Keywords: glaucoma, ocular hypertension, bimatoprost, preservative-free, ophthalmic gel