, Volume 73, Issue 9, pp 949-958
Date: 06 Jun 2013

Loteprednol Etabonate Ophthalmic Gel 0.5 %: A Review of Its Use in Post-Operative Inflammation and Pain Following Ocular Surgery

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Abstract

Loteprednol etabonate ophthalmic gel 0.5 % (Lotemax®) is approved in the USA for the treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. The new gel formulation of loteprednol etabonate offers some potential advantages over the previously available ophthalmic suspension and ointment formulations of the drug. Because the gel is non-settling, a uniform dose of loteprednol etabonate is delivered without the need to vigorously shake the product. The pH of the gel formulation is close to that of physiological tears and the concentration of preservative is low. In clinical trials, loteprednol etabonate ophthalmic gel 0.5 % for 14 days was effective, very well tolerated and safe when used for the treatment of post-operative inflammation and pain following cataract surgery. Relative to vehicle, loteprednol etabonate ophthalmic gel 0.5 % effectively reduced postoperative ocular inflammation and ocular pain and had a similar overall tolerability, comfort and safety profile. It is associated with a low risk of inducing clinically significant increases in intraocular pressure. In conclusion, loteprednol etabonate ophthalmic gel 0.5 % is an additional formulation option for the short-term treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. It provides uniform dosing of a topical ophthalmic corticosteroid that has been demonstrated to be effective and well-tolerated in the treatment of ocular inflammation.

The manuscript was reviewed by: R.G. Fiscella, Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, IL, USA, R.K. Rajpal, See Clearly Vision Group, McLean, VA, USA.