Preservative-free 0.01% bimatoprost versus other formulations for glaucoma and OHT: Systematic review and meta-analysis of efficacy and safety

PurposeTo demonstrate non-inferiority on efficacy and safety of preservative-free bimatoprost 0.01% versus preserved and higher-concentration bimatoprost formulations for the treatment of glaucoma or ocular hypertension (OHT), using a network meta-analysis (NMA).MethodsA systematic review and Bayesian NMA were conducted according to a pre-registered protocol (PROSPERO: CRD420250650769) and PRISMA-NMA guidelines. Randomised controlled trials comparing monotherapies of bimatoprost (preserved or preservative-free) in adults with glaucoma or OHT were included. The primary endpoint was mean intraocular pressure (IOP) at Week 12. Conjunctival hyperaemia, were descriptively analysed. Risk of bias was assessed using the Cochrane RoB 2 tool.ResultsFour studies were included. The Bayesian NMA demonstrated that preservative-free bimatoprost 0.01% was non-inferior to all other bimatoprost formulations in lowering IOP, with all 95% credible intervals falling within the 1.5 mmHg non-inferiority margin. Sensitivity analyses using a frequentist model confirmed these findings. Safety analysis indicated that preservative-free bimatoprost formulations were associated with lower rates of hyperaemia compared to preserved versions. At Week 12, more patients had no hyperaemia with preservative-free bimatoprost 0.01% (57.3% vs. 43.6%) and fewer showed worsening scores (18.3% vs. 30.4%). Hyperaemia reported as an adverse event was also less frequent with bimatoprost 0.01% than 0.03% (28.6% vs. 37.4%).ConclusionsPreservative-free bimatoprost 0.01% provided IOP-lowering efficacy similar to preserved or higher-dose bimatoprost, with less occurrence of conjunctival hyperaemia. Further long-term studies are needed to confirm these benefits.