Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery

• Published in: Clinical drug investigation 2020-04, Vol.40 (4), p.387-394
• Main Authors: Kang, Connie, Keam, Susan J., Shirley, Matt, Syed, Yahiya Y.
• Format: Article
• Language: English
• Subjects: Adis Drug Evaluation; Anti-Allergic Agents - administration & dosage; Cataract Extraction - adverse effects; Cataracts; Drug dosages; Edema; Eye surgery; FDA approval; Gels; Humans; Inflammation; Inflammation - drug therapy; Internal Medicine; Intraocular Pressure - drug effects; Loteprednol Etabonate - administration & dosage; Medicine; Medicine & Public Health; Pain; Pain, Postoperative - drug therapy; Particle size; Patient satisfaction; Pharmacology/Toxicology; Pharmacotherapy; Postoperative Complications - drug therapy; Randomized Controlled Trials as Topic; Rheology; Shear stress; Visual Acuity - drug effects
• ISSN: 1173-2563; 1179-1918
• DOI: 10.1007/s40261-020-00899-2

Loteprednol etabonate ophthalmic gel 0.38% (Lotemax ® SM; hereafter referred to as loteprednol etabonate gel 0.38%) is a topical ophthalmic corticosteroid approved in the USA for the treatment of post-operative inflammation and pain following ocular surgery. This formulation provides improved drug delivery compared with loteprednol etabonate micronized gel 0.5%, with a smaller drug particle size (in the submicron range) to improve dissolution and penetration into ocular tissues, meaning less loteprednol etabonate is required to exert therapeutic effect. In two multicentre, randomized phase III trials, significantly more loteprednol etabonate gel 0.38% than vehicle recipients displayed complete resolution of ocular inflammation and ocular pain at day 8 post cataract surgery. Complete resolution of pain was seen as early as post-operative day 3. Treatment-related ocular adverse events in the loteprednol etabonate gel 0.38% group occurred in