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Ampio Pharmaceuticals Inc. has announced the interim results from its ongoing 450 patient, dose finding, 505 (b) 2 study of Optina as a treatment for diabetic macular edema (DME).
Greenwood Village, CO-Ampio Pharmaceuticals Inc. has announced the interim results from its ongoing 450 patient, dose finding, 505 (b) 2 study of Optina as a treatment for diabetic macular edema (DME).
The interim analysis was conducted by an independent data review committee (IDRC) comprised of a statistician and an ophthalmologist/retinologist, who were permitted to view the unmasked data from the trial.
At least 30% of patients enrolled in the trial had reached the first 4-week time point and their clinical results were considered representative data for the trial.
“After thorough review of the interim data from the ongoing study, it was determined that there was a treatment dosage that was demonstrating a potentially beneficial anatomic effect,” noted Vaughan Clift, MD, chief regulatory officer for Ampio. “Given that there were no significant safety concerns identified in the study to date, a recommendation to continue the trial was made.”
The IDRC’s recommendation, Dr. Clift said, will allow for the continuation and completion of the trial and initiate an open label extension study using the found dose of the drug.
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