The Food and Drug Administration (FDA) has approved Lotemax SM (loteprednol etabonate ophthalmic gel; Bausch + Lomb) 0.38% for the treatment of postoperative inflammation and pain following ocular surgery.
Lotemax SM is a submicron gel formulation of loteprednol, a corticosteroid, that allows for improved drug exposure into the aqueous humor. The approval was based on data from 2 double-masked, parallel group, vehicle-controlled trials in patients who underwent cataract extraction with intraocular lens implantation.
Results showed that a significantly greater proportion of patients treated with Lotemax SM had complete clearing of anterior chamber cells when compared with vehicle (Study 1: 29% vs 9%; Study 2: 31% vs 20%). In addition, more patients treated with Lotemax SM had complete resolution of pain at post-operative Day 8 (Study 1: 73% vs 48%; Study 2: 76% vs 50%). With regard to safety, no treatment-emergent adverse events occurred in >1% of patients treated with Lotemax SM compared with vehicle.
Lotemax SM will be supplied as a sterile preserved ophthalmic gel containing 3.8mg of loteprednol etabonate per gram of gel. It is expected to be available in April 2019.
For more information visit bauschhealth.com.