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.