Positive results for Optina (Ampio) in patients with Diabetic Macular Oedema

Ampio announces positive clinical trial results for the treatment of Diabetic Macular Oedema with orally administered Optina (danazol). The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT). The study included 32 patients with moderate to severe Diabetic Macular Oedema (range 316-707 microns) that were treated orally with either placebo or one of three doses of Optina. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina. 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 the drug. 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 12 weeks, which was statistically significant from placebo for the higher BMI group. Dose adjustments by body weight/BMI of Optina will be part of the design of the company's next trial. Ampio has requested and received confirmation of a pre-IND meeting with the FDA on Optina for Diabetic Macular Oedema, which will take place in July 2012.