26 September 2014. A clinical trial of more than 500 patients shows a lower-dose formulation of a current medication reduces eye pain and inflammation among more post-surgical cataract patients than a placebo. Bausch and Lomb, a subsidiary of Valeant Pharmaceuticals in Laval, Quebec, Canada, reported today results of the late-stage clinical trial.
The trial tested a lower concentration of Bausch and Lomb’s drug Lotemax, prescribed to relieve inflammation and pain following surgery on the eyes. Lotemax is a form of the corticosteroid compound loteprednol etabonate, currently administered as a gel in concentrations of 0.5 percent. The study tested Lotemax in a concentration of 0.38 percent, which the company says was possible because of sub-micron particles — less than 1 millionth of a meter — that in preclinical tests were able to get greater penetration than the standard formulation.
For the clinical trial, Bausch and Lomb enrolled 514 patients who underwent cataract surgery without complications and who experienced between 6 and 15 white blood cells in the anterior chamber, part of the eye between the cornea and iris, an indicator of inflammation following surgery. Patients were recruited at 47 sites in the U.S.
Enrolled patients were randomly divided into four groups: two groups receiving the lower concentration of loteprednol etabonate gel 2 or 3 times a day for 14 days, and two other groups using a placebo ointment — in this case, the same gel but without the drug mixed in — also 2 or 3 times a day for 14 days. Patients were assessed after day 7, half way through the study period, where researchers looked primary for removal of all anterior chamber cells and reports of no pain (grade-0) on a standard chronic pain scale. Researchers also looked for evidence of cells in the anterior chamber and grade-0 pain reports after day 14, as well as problems related to the anterior chamber.
The company reported findings that show more patients using the lower-concentration ointment either 2 or 3 times a day experience complete removal of anterior chamber cells as well as report no pain after day 7, than their counterparts receiving the placebo. After day 14, more patients continue to report removal of all anterior chamber cells and grade-0 pain in the eyes. In addition, the need for rescue medication is higher among placebo patients. While safety issues were not part of the trial, the company says no safety problems were reported.
Bausch and Lomb is planning a second clinical trial, comparing effectiveness of the lower-concentration Lotemax ointment given twice a day compared to a placebo; that trial is not yet accepting patients. The company plans to file a new drug application with the U.S. Food and Drug Administration in the second half of 2015 based on results of these studies.
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