General Information

Lotemax (loteprednol etabonate ophthalmic ointment) 0.5% is a topical, site-specific steroid.

Lotemax is specifically indicated for the treatment of postoperative inflammation and pain following ocular surgery.

Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Mechanism of Action

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

Side Effects

Adverse effects associated with the use of Lotemax may include, but are not limited to, the following:

• anterior chamber inflammation
• conjunctival hyperemia
• corneal edema
• eye pain

Clinical Trial Results

In two independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 805 subjects meeting a protocol-specified threshold amount of anterior chamber inflammation, Lotemax ointment was more effective compared to its vehicle for complete resolution of post-operative anterior chamber cell, flare, and pain following cataract surgery. Primary endpoint was complete resolution of anterior chamber cells and flare (cell count of 0 and no flare) and no pain at post-operative Day 8. In the two studies, Lotemax had statistically significant higher incidence of complete clearing of anterior chamber cells and flare at post-operative Day 8 (24-32% vs. 11-14%) and also had a statistically significant higher incidence of subjects that were pain free at post-operative Day 8 (73-78% vs. 41-45%).