E Shares Of Ampio Are Up On Positive Results In Diabetic Macular Edema

Shares of Ampio Pharmaceuticals (AMPE) are up about 18% today after the company reported positive results in patients being treated with Diabetic Macular Edema. The trial was known as the "OptimEyes" trial that recruited patients to be treated with Optina, Ampio's Diabetic Macular Edema -- DME -- drug. The trial was split up into two different dosing groups. One group took Optina treatment while the other group was given a placebo compound instead. 

The results in themselves were strong because of the patients that were recruited into the trial. Ampio discussed many recruitment options with the FDA, and the ultimate conclusion was that the FDA wanted to include a wide variety of DME patients. This means that the FDA wanted to include the DME patients who were going blind because of failed previous therapies. 

The goal of the OptimEyes trial was to do two things. The first was for the trial to assess the safety profile of patients receiving Optina. The second goal was to assess the efficacy of Optina in patients with DME. In terms of safety the Optina treatment was well tolerated and the side effects were similar to those of the placebo compound. 

Positive efficacy results were seen in a set of subgroup of patients. For instance 53% of the patients were unable to be treated with intraocular injection therapy, and these patients showed a 6.2 + letter improvement in visual acuity. In addition patients taking Optina displayed a reduction of retinal swelling by 46 microns,which translates to a p-value of p = 0.003 which means the endpoint of the study was met. On the other hand the placebo compound displayed a reduction of retinal swelling by -12 microns, a p-value of p = 0.47 which totally was off compared to the active compound. Now Ampio is awaiting further guidance from the FDA before deciding the next step for the Optina program. 

Disclosure: no positions mentioned

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