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

Abstract

PurposeLoteprednol 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 methodsThis 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.ResultsA 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.ConclusionLE gel 0.5% was efficacious and safe in treating postoperative inflammation and pain in this clinical study.

Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty

“…6 A 0.5% nonsettling gel formulation of loteprednol etabonate received approval for the treatment of postsurgical inflammation based on randomized placebo-controlled trials that evaluated 14-day use after cataract surgery. 10,11 The purpose of this study was to evaluate the efficacy and safety of loteprednol etabonate 0.5% gel compared with prednisolone acetate 1% suspension when used to prevent immunologic rejection during the first year after DMEK.…”

Prolonged Exposure to Loteprednol Etabonate in Human Tear Fluid and Rabbit Ocular Tissues Following Topical Ocular Administration of Lotemax Gel, 0.5%

“…These results are consistent with results from clinical studies with LE ophthalmic gel, 0.5% for the treatment of patients with postcataract pain and inflammation, which reported very few adverse events, mostly related to the surgical procedure itself. 34,35 Most topical steroids are formulated as suspensions, which require vigorous shaking before administration to resuspend the drug. This may be problematic for patients who forget to shake the bottle or do not shake it well enough.…”

“…The efficacy and safety of LE ophthalmic gel 0.5% were demonstrated in 2 randomized, doublemasked, vehicle-controlled studies in patients following uncomplicated cataract surgery. 34,35 In each study, patients self-administered either LE gel or vehicle 4 times per day for 14 days following surgery. At postoperative Day 8 and 15, a significantly greater proportion of patients treated with LE gel were pain free and had complete resolution of anterior chamber cells compared to patients treated with vehicle (P < 0.001).…”

Critical appraisal of loteprednol ointment, gel, and suspension in the treatment of postoperative inflammation and pain following ocular and corneal transplant surgery

“…No adverse reactions to medications were noted. Furthermore, the authors showed 75.7% of LE-treated patients and 45.8% of vehicle-treated patients had no pain (grade 0) 34. In comparative studies evaluating LE suspension 0.5%, other corticosteroids, or NSAIDs, Stewart found no statistically significant difference in efficacy between the LE- and fluorometholone acetate 0.1%-treated groups.…”