GREENWOOD VILLAGE, Col. (
(AMPE - Get Report)
announced Monday "positive clinical trial results" from a study of a low-dose generic steroid in diabetic macular edema that looks much more like a failure.
The study in question enrolled 32 patients with diabetic macular edema (DME), or swelling of the central portion of the retina caused by damaged and leaky blood vessels. DME can occur in patients with diabetes, and if untreated, can lead to blindness.
Ampio treated the 32 DME patients with one of three oral doses of Optina, a low-dose reformulation of the generic steroid danazol, or a placebo. Ampio claims low doses of danazol can reverse inflammation thereby making blood vessels less leaky. To test this theory, the Optina study's primary endpoint was the reduction of macular edema after four and 12 weeks of treatment, assessed using a device that measures the thickness of the retina.
The Optina study failed. No statistically significant difference in retinal thickness was measured between patients treated with any three of the Optina doses compared to a placebo. The only glimmer of optimism came from the lowest dose of Optina showing a trend towards reduced retinal thickness over placebo; that result, however, was not statistically significant, Ampio said.
The highest dose of Optina tested in the study didn't produce a benefit for DME patients, according to an Ampio statement issued in March. On Monday, Ampio said nothing about the performance of mid- and high-dose Optina dose groups, but Vaughan Clift, Ampio's chief regulatory officer, told me in a phone call Monday that no significant benefit in either the middle or high-dose Optina patients was observed in the study.
Yet Clift strongly disagreed with any suggestion that the Optina study was a failure. He insisted that not only was the study an absolute success, but the data show Optina to be "the most exciting development in diabetic eye care in the last 30 years… We can stop blindness."
True, if you believe in Ampio's spin, er… I mean… interpretation of data reportedly demonstrating Optina can reduce retinal thickening as long as the dose is aligned correctly with the body mass index (BMI) of the patient.