Preservative-free bimatoprost (PFB) 0.01% ophthalmic gel has the same efficacy in lowering intraocular pressure (IOP) as preserved bimatoprost (PB) 0.01% ophthalmic solution, but demonstrated less aggravation of conjunctival hyperemia at weeks 6 and 12, a recent phase 3 study sponsored by Thea Pharmaceuticals has concluded.1 According to data published in the Journal of Glaucoma, a total of 485 patients with open-angle glaucoma or ocular hypertension were randomized to receive once-daily PFB 0.01% gel (n=236) or bimatoprost 0.01% (n=249) preserved with benzalkonium chloride (BAK) for 3 months. The primary efficacy measure was change from baseline in IOP at week 12. Safety measures included adverse events (AEs) and assessment of conjunctival hyperemia.
A comparable reduction in IOP was observed with both PFB and PB at all time points, at both 6 and 12 weeks after the initiation of therapy. Patients treated with PFB had lower rates of conjunctival hyperemia at week 6 (47.6%) and week 12 (42.7%) than those treated with PB (58.2% and 56.4%, respectively). The frequency of subjective symptoms of eye dryness and irritation was also significantly different, favoring PFB treatment. “These results … suggest that this new preservative-free gel formulation of bimatoprost 0.01% could provide a therapeutic advantage over preservative-containing formulations in terms of patient adherence and persistence,” the study authors concluded.
References
1. Muñoz-Negrete FJ, Topouzis F, Oddone F, et al. Preservative-free bimatoprost 0.01% ophthalmic gel for glaucoma therapy: a phase 3 randomized controlled trial. J Glaucoma. 2024;33(6):422-430. doi:10.1097/IJG.0000000000002371
