Preservative-Free Bimatoprost gel Equally Effective with Fewer Side Effects in Glaucoma Treatment: Study

Open-angle glaucoma and ocular hypertension are common conditions that require effective management to prevent vision loss. Bimatoprost 0.01% is a widely used medication for lowering IOP, but its formulation often includes preservatives like benzalkonium chloride (BAK), which can cause adverse reactions such as conjunctival hyperemia. This study aimed to compare the efficacy and safety of preservative-free bimatoprost 0.01% (PFB 0.01% gel) with preserved bimatoprost 0.01% (PB 0.01%).

This phase III study enrolled patients who had undergone a 7-week run-in/washout period. A total of 485 patients were randomized to receive either PFB 0.01% gel (n=236) or PB 0.01% (n=249) once daily for 3 months. The primary efficacy measure was the change from baseline in IOP at week 12, with safety measures including adverse events and the assessment of conjunctival hyperemia.

The results demonstrated that both formulations significantly lowered IOP:

• At 8 am: PFB 0.01% gel reduced IOP by -9.72±2.97 mm Hg, compared to -9.47±3.06 mm Hg with PB 0.01%.

• At 10 am: PFB 0.01% gel lowered IOP by -9.41±3.03 mm Hg, while PB 0.01% achieved a reduction of -9.19±3.12 mm Hg.

• At 4 pm: IOP reduction was -8.99±3.36 mm Hg with PFB 0.01% gel and -8.54±3.44 mm Hg with PB 0.01%.

• Noninferiority of PFB 0.01% gel was established based on predetermined criteria, with the upper 95% confidence interval margin of 1.5 mm Hg at all time points.

• The most frequently reported adverse event was conjunctival hyperemia. The incidence was slightly lower in the PFB 0.01% gel group (5.5%) compared to the PB 0.01% group (6.8%).

• Fewer patients experienced worsening conjunctival hyperemia with PFB 0.01% gel at both week 6 (20.1% vs. 29.3%) and week 12 (18.3% vs. 30.4%).

The findings suggest that preservative-free bimatoprost 0.01% gel offers an effective alternative to preserved formulations, particularly for patients who are prone to ocular surface side effects. The reduction in conjunctival hyperemia is a significant advantage, enhancing the overall tolerability of the treatment.

The study concludes that preservative-free bimatoprost 0.01% ophthalmic gel provides comparable efficacy in IOP reduction to preserved bimatoprost 0.01%, with the added benefit of fewer adverse effects such as conjunctival hyperemia. This makes it a preferable option for long-term management of open-angle glaucoma and ocular hypertension.

Reference:

Muñoz-Negrete, F. J., Topouzis, F., Oddone, F., Nisslé, S., Rokicki, D., Januleviciene, I., Harasymowycz, P., & Stalmans, I. (2024). Preservative-free bimatoprost 0.01% ophthalmic gel for glaucoma therapy: A phase III randomized controlled trial. Journal of Glaucoma, 33(6), 422–430. https://doi.org/10.1097/ijg.0000000000002371