Results positive for B+L sub-micron gel formulation of loteprednol etabonate

Laval, Quebec-Bausch + Lomb’s next-generation sub-micron gel formulation of loteprednol etabonate has been found to be statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day 8-the primary endpoints in the first phase III, multicenter, double-masked, vehicle-controlled, parallel-group study.

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The 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%) than the company's currently marketed loteprednol etabonate ophthalmic gel 0.5% (Lotemax).

Based on the preclinical data, the 0.38% sub-micron formulation demonstrated enhanced drug penetration to vital ocular tissues related to the treatment of post-operative inflammation as compared to the 0.5% loteprednol etabonate ophthalmic gel and the 0.5% suspension formulas.

In the four-arm study, 514 patients undergoing cataract surgery at 47 clinical sites across the United States were randomly assigned to receive either sub-micron loteprednol etabonate ophthalmic gel (0.38%) or a vehicle gel in four treatment groups, either three times daily or two times daily, for about 14 days. The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber 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 8.

At study day 8, a statistically significant difference favoring the active groups was achieved for complete resolution of inflammation (BID p = 0.0001; TID p < 0.0001). Complete resolution of eye pain by day 8 was similarly achieved with statistical significance by patients receiving sub-micron loteprednol etabonate ophthalmic gel (0.38%) (BID p <0.0001; TID p <0.0001). 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 (p <0.0001) than in either active treatment arms.

There were no significant safety findings.

"Both published research and my own personal experience suggest that asking patients to use eye drops more than two times a day significantly impacts compliance, even during a 2-week course of postoperative therapy," said Gregg J. Berdy, MD, FACS, assistant professor of clinical ophthalmology at Washington University School of Medicine in St. Louis, MO, and an investigator in the study. "Inflammation and pain following cataract surgery can complicate post-operative recovery and compromise visual outcomes. The prospect that both inflammation and pain could be reduced after surgery with BID dosing of this new sub-micron loteprednol etabonate formulation is therefore very appealing."

"Following the positive clinical results…, these promising results continue to demonstrate Valeant's commitment to funding and developing innovative ophthalmic pharmaceuticals compounds," said J. Michael Pearson, chairman and chief executive officer, Valeant Pharmaceuticals International. "This initial phase III study highlights our ophthalmic formulation expertise and validates that (it) is beneficial at a lower concentration and with less frequent dosing than our current formulation.”

Full results from the study will be presented at a future ophthalmic congress, according to Bausch + Lomb.

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