TOPLINE: 

In patients with open-angle glaucoma or ocular hypertension, 3-month treatment with a preservative-free ophthalmic gel of bimatoprost 0.01% was noninferior to the commercially available preserved ophthalmic solution of bimatoprost 0.01% for lowering intraocular pressure, with similar safety and tolerability profiles.

METHODOLOGY:

• Researchers conducted a prospective, phase 3 study at multiple centers across the United States, Colombia, and Canada between June 2022 and March 2024 to assess the efficacy and safety of preservative-free vs preserved formulations of bimatoprost in patients with open-angle glaucoma or ocular hypertension.
• They included 466 patients (mean age, 67.4 years; 53.7% women) with intraocular pressures between 22 mm Hg and 34 mm Hg in both eyes and an asymmetry of no more than 4 mm Hg between eyes; all patients had received antiglaucoma monotherapy for at least 30 days and underwent a washout period of up to 7 weeks.
• Patients were randomly assigned to receive one drop of either preservative-free bimatoprost 0.01% gel (n = 232) or preserved bimatoprost 0.01% solution (n = 234) in each eye once daily for 3 months.
• The primary endpoint for the assessment of efficacy was the change in intraocular pressure from baseline at weeks 2, 6, and 12, each assessed at 8 AM, 10 AM, and 4 PM. Noninferiority was established if the differences in intraocular pressure between the two groups remained below 1.5 mm Hg at all nine timepoints and below 1 mm Hg at most timepoints.
• Safety measures assessed included adverse events, redness of eyes, and other ocular signs and symptoms. Global tolerance and the satisfaction of patients were also assessed.

TAKEAWAY:

• The researchers found consistent reductions in intraocular pressure from baseline across all timepoints, with similar effects in both treatment groups.
• The preservative-free gel of bimatoprost 0.01% was noninferior to the preserved solution of bimatoprost 0.01%, according to the defined noninferiority margins.
• Overall safety and tolerability profiles were comparable between the two groups; compared with the preserved solution, fewer patients receiving the preservative-free gel had redness of eyes at week 2 (54.8% vs 63.2%) or treatment-related ocular adverse events (28.1% vs 34.8%).
• The overall tolerance and efficacy of the preservative-free gel of bimatoprost were each rated as "very satisfactory" or "satisfactory" by most patients and investigators.

IN PRACTICE:

"Given the chronic nature of topical glaucoma therapy, the availability of a [preservative free] alternative may offer meaningful benefits for patients who are newly diagnosed, have preexisting ocular surface conditions or are at risk of cumulative preservative exposure. Such an option may help support better ocular surface health and treatment adherence over time," the researchers reported.

SOURCE:

This study was led by Eydie Miller-Ellis, MD, of the University of Pennsylvania in Philadelphia. It was published online on September 15, 2025, in the Journal of Glaucoma.

LIMITATIONS: 

Treatment for 3 months might be inadequate to reflect the long-term side effects, impact on progression of disease, or changes in ocular surface health. The generalizability of the study was limited as 61.4% of patients were White. This study evaluated only monotherapy; thus, the results may not apply to patients using multiple treatments for lowering intraocular pressure.

DISCLOSURES:

This study received funding from Laboratoires Théa. Six authors reported receiving financial compensation as investigators of this study. One author reported being employed by Laboratoires Théa.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.