FDA approves Lotemax SM for postoperative pain in ocular surgery.- Bausch + Lomb

Bausch + Lomb announced that the FDA has approved Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery. Compared to Lotemax GEL (loteprednol etabonate ophthalmic gel) 0.5%, Lotemax SM delivers a submicron particle size for faster drug dissolution in tears. Lotemax SM also provides two times greater penetration to the aqueous humor compared to Lotemax GEL.

The FDA approval of Lotemax SM was based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 patients with postoperative inflammation following cataract surgery. Lotemax SM was administered three times daily to the affected eye beginning the day after surgery and was shown to be significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery. In these two studies, twice as many patients treated with Lotemax SM achieved complete inflammation resolution at day eight compared to vehicle (30 percent vs. 15 percent). Additionally, significantly more patients treated with Lotemax SM were pain-free compared to vehicle at day eight (74 percent vs. 49 percent) and day three (secondary endpoint; 72 percent vs. 50 percent). In the studies, Lotemax SM had a proven safety profile. There were no treatment-emergent adverse drug reactions that occurred in more than one percent of the subjects in the three times daily group compared to vehicle.