B+L announce successful Phase 3 study results of new ophthalmic gel

Laval, Canada-Bausch + Lomb recently announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo in eliminating inflammation and pain following cataract surgery by study Day 8, the primary endpoints in the first Phase 3, multi-center, double-masked, vehicle-controlled, parallel-group study.

According to Bausch + Lomb, new gel formulation features a sub-micron particle size, intended to enhance tissue penetration of the drug, and a lower concentration of loteprednol etabonate (0.38 percent) than the company's currently-marketed Lotemax (loteprednol etabonate ophthalmic gel 0.5 percent). Based on the preclinical data, the 0.38 percent submicron formulation demonstrated enhanced drug penetration to key ocular tissues related to the treatment of post-operative inflammation as compared to the 0.5 percent Lotemax Gel and the 0.5 percent Lotemax suspension formulas.

In the four-arm study, 514 patients undergoing cataract surgery at 47 clinical sites across the U.S. were randomized to receive either sub-micron loteprednol etabonate ophthalmic gel (0.38 percent) or a vehicle gel in four treatment groups, either three times daily or two times daily, for approximately 14 days. The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber cells (i.e. zero cells), a marker of ocular inflammation, in the study eye at Day 8 and the proportion of subjects with Grade 0 pain in the study eye at day eight.

At study Day 8, a statistically significant difference favoring the active groups was achieved for complete resolution of inflammation. Complete resolution of eye pain by day eight was similarly achieved with statistical significance by patients receiving sub-micron loteprednol etabonate ophthalmic gel (0.38 percent). Statistical superiority for the active groups was maintained in both endpoints for the remainder of the study period (at Day 15 and at a follow-up safety visit on Day 18). Rescue medication use was significantly higher in the vehicle arm than in either active treatment arms. There were no significant safety findings.