Ampio Pharmaceuticals Inc., of Englewood, Colo., said, in response to requests from patients and physicians, the company has performed an analysis of the available data from both portions of the Optimeyes study testing Optima in diabetic macular edema (DME). Data from the blinded 359-patient study are still masked but early data indicate that, overall, from baseline to the end of the open-label period, 72 percent of patients saw improvements or stabilizations in their vision as measured by Best Corrected Visual Acuity (BCVA) and mean BCVA increased significantly (p < 0.0001) after adjusting for baseline values. Sixty-two percent of patients saw improvements in central retinal thickness as measured by Optical Coherence Tomography (OCT), and mean OCT decreased significantly (p < 0.0001) after adjusting for baseline values. Given those data, Ampio said it plans to request the FDA to allow it to unmask the trial, complete the analysis and present all the data. Optima is an ultra-low-dose version of danazol aimed at delaying the progression to blindness in DME patients.

Boston Therapeutics Inc., of Manchester, N.H., said it completed enrollment in its phase IIb trial of BTI-320, a nonsystemic, new generation alpha glucosidase inhibitor-based tablet aimed at reducing postmeal elevation of blood glucose. The U.S. study, SD-002, enrolled patients with type 2 diabetes currently treated with metformin using a randomized, double-blind, placebo-controlled, dose-ranging, three-way crossover study design. The primary endpoint of the study is the evaluation of the effect of BTI-320 compared to placebo in the area under the curve of glucose and, secondarily, on insulin levels in the blood for four hours following intake of the meal.