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Gel formulation lowers inflammation, pain following cataract surgery
Consistency, comfort seen as advantages of loteprednol etabonate 0.5% gel preparation.
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A new gel formulation of loteprednol etabonate treated inflammation and pain after cataract surgery without elevating IOP, according to a study.
“It seems to be extremely efficacious in decreasing inflammation, and it also has the benefit of not having serious side effects or adverse events,” study author and OSN Refractive Surgery Board Member Rajesh K. Rajpal, MD, said. “Most importantly, the rate of patients with IOP elevation in this study was extremely low.”
Study data
The prospective, double-masked, parallel-group study included 406 patients; half were randomized to receive Lotemax (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb) four times a day for 14 days. The other half were randomized to receive placebo four times a day for 14 days. Results were published in the Journal of Cataract and Refractive Surgery.
“Unlike the current suspension formulations, the gel is non-settling and does not require shaking to re-suspend the drug particles, and it provides consistent dose uniformity,” the study authors wrote. “The new formulation has a more physiologic pH, and the concentration of benzalkonium chloride concentration has been reduced from 0.01% to 0.003%.”
The study included patients who were scheduled for routine phacoemulsification with posterior chamber IOL implantation and had the potential for postoperative corrected distance visual acuity of 20/200. All patients had anterior chamber cell grade 2 or higher.
On day 8, 30.5% of patients in the treatment group and 16.3% of patients in the placebo group had complete resolution of anterior chamber flare, and 72.9% of patients in the treatment group and 41.9% of patients in the placebo group reported no pain (both P < .001); both were primary endpoint measures.
The mean change for anterior chamber flare from baseline was significantly better in the treatment group than in the placebo group (P < .001) at all postoperative follow-up visits.
Only one patient in each treatment group experienced an increase in IOP from baseline of more than 10 mm Hg.
Approximately 85% of all patients reported no discomfort during drop instillation, according to the study. Fewer patients required rescue medication in the treatment group than in the placebo group.
The option of an additional steroid with fewer side effects and fewer instances of elevated IOP should be appealing to clinicians, Rajpal said.
“It also has moisturizers that are more soothing to the surface of the eyes, and it has less preservative than the old version of Lotemax,” he said.
Benefits of treatment
According to Rajpal, the main benefit of the gel is its different formulation.
“The gel has a greater retention time on the surface of the cornea, thus hopefully allowing better absorption of the active ingredient into the cornea and into the eye, so that it gets to the site of action,” he said.
This formulation also affords more convenience for patients, according to the authors.
“Because patients may not always follow instructions and vigorously shake suspension formulations before use, the non-settling nature of the gel formulation provides consistent dose uniformity and ease of instillation for patients,” the study authors wrote.
Dose uniformity and frequency should be analyzed in future studies, potentially allowing for a less frequent dosing regimen, Rajpal said.
“There should be studies done to verify whether we can use it ultimately less frequently,” he said. “Compliance is better if we’re able to use a drop less frequently and have the same level of absorption, and therefore have the same level of efficacy.” – by Ashley Biro