Bausch + Lomb: Med met primary endponts in eye surgery pain study

Bausch + Lomb, a wholly owned subsidiary of Bausch Health, announced that the Journal of Cataract and Refractive Surgery has published results of a pivotal Phase 3, multicenter, double-masked, vehicle-controlled, randomized, parallel-group study that evaluated the clinical safety and efficacy of submicron loteprednol etabonate ophthalmic gel, 0.38%. In the study, this investigational formulation of loteprednol etabonate met both of the primary efficacy endpoints in that it was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery. Additionally, the results showed that submicron loteprednol etabonate ophthalmic gel, 0.38% had an acceptable safety profile regardless of whether it was administered two or three times per day. Submicron loteprednol etabonate ophthalmic gel, 0.38% has a reduced concentration and reduced dosing frequency versus existing formulations of loteprednol etabonate. The published Phase 3 study, which enrolled 514 patients, showed that a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% dosed twice daily or three times daily had complete resolution of anterior chamber cells on postoperative day 8 compared with the vehicle group. Similarly, a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily or three times daily had no ocular pain on day 8 compared with the vehicle group. For patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% group, statistically significant differences in both anterior chamber cells and ocular pain were sustained at all subsequent visits relative to vehicle. Additionally, significantly fewer patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily group and three times daily group required rescue medication by day 8 compared with those in the vehicle group. The most common ocular adverse events were eye pain, photophobia, and foreign body sensation. The U.S. Food and Drug Administration has accepted the New Drug Application for submicron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act action date of Feb. 25, 2019.

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