GREENWOOD VILLAGE, Colo., June 11, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina™ clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.
Dr. David Bar-Or, Ampio's Chief Science Officer (CSO), explained "The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT) and reported in microns. The study was double masked and included 32 patients with moderate to severe diabetic macular edema (range 316-707microns) that were treated orally with either placebo or one of three doses of Optina™. Central retinal thickness and retinal volumes were measured at baseline and at 4 and 12 weeks of treatment. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina™. For higher BMI (BMI=35) patients, higher doses of Optina™ were more effective and for lower BMI (BMI=26) patients, lower doses were more effective. The improvement of efficacy by adjusting the dose to the BMI is in agreement with both in vitro data as well as with the known strongly lipophilic nature of Optina™. At one of the low doses, regardless of BMI, there was a reduction of the subfield central retinal thickness of approximately 20% at 4 and at 12 weeks, which was statistically significant from placebo for the higher BMI group (p = 0.01). The lowest dose of Optina™ showed a trend towards statistically significant reductions in central retinal thickness in the lowest BMI groups (p = 0.11 and p = 0.13) at 4 and 12 weeks, despite the small number of patients randomized to this dose.