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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.
This article originally appeared on MPR
