Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial

Abstract

Purpose

Loteprednol etabonate (LE) is approved by the US FDA in a suspension and ointment form (0.5%) for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH.

Patients and methods

This multicenter, double-masked, parallel-group, vehicle-controlled study randomized patients aged ≥18 years with postoperative anterior chamber cell (ACC) ≥ grade 2 following uncomplicated cataract surgery to either LE gel or vehicle four times a day for 14 days. Primary efficacy end points included the proportion of patients with complete resolution of ACC and grade 0 (no) pain by postoperative day 8. Secondary efficacy end points included complete resolution and change from baseline in ACC and flare (individual and combined), and grade 0 pain at each visit. Safety end points included treatment-emergent adverse events, ocular symptoms, changes in intraocular pressure (IOP) and visual acuity, and biomicroscopy and funduscopy findings.

Results

A total of 407 patients were randomized to treatment (n = 206, LE gel; n = 201, vehicle). At day 8, 31.1% (64) of LE-treated patients and 13.9% (28) of vehicle-treated patients had complete resolution of ACC (P < 0.001), and 75.7% (156) of LE-treated patients and 45.8% (92) of vehicle-treated patients had grade 0 pain (P < 0.001). Secondary efficacy end points also favored LE gel. Fewer patients treated with LE gel required rescue medication (10.7% versus 42.3%) prior to day 15, and fewer had an ocular adverse event (16.0% versus 28.9%, P = 0.002). No drug-related adverse effects were reported more than once in the LE group. Mean IOP decreased in both treatment groups; one patient in the LE group demonstrated a clinically significant increase (≥10 mm Hg) in IOP that was not considered drug-related. Visual acuity and funduscopy findings were similar between treatments.

Conclusion

LE gel 0.5% was efficacious and safe in treating postoperative inflammation and pain in this clinical study.

Keywords:

• cataract surgery
• corticosteroids
• gel
• loteprednol etabonate
• postoperative inflammation
• postoperative pain

Acknowledgments

Medical writing services were provided by Cactus Communications and were funded by Bausch and Lomb. The authors retained full control of the manuscript content.

Disclosure

Raymond Fong has been a speaker for Bausch and Lomb. Raphaele Siou-Mermet and Tara Erb are employees of Bausch and Lomb. Martin Leitritz has no potential conflicts to declare.