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Ampio Announces Positive Preliminary Update on the Optina™ Clinical Trial to Treat Diabetic Macular Edema and Decision to Conclude the Study Ahead of Schedule
Date:3/19/2012

age for the FDA that includes the basic science and clinical results for discussion of the design of a pivotal trial in the US under the 505(b)2 regulation for repurposed drugs. A detailed analysis of the study results will follow pending the completion of data analysis by our CRO."

About Diabetic Retinopathy, Diabetic Macular Edema and current treatments
Dr. David Bar-Or, Chief Scientific Officer of Ampio, noted, "Diabetic retinopathy is damage to the retina of the eyes caused by complications of diabetes mellitus and often resulting in loss of visual acuity and blindness.  Macular edema of the eyes is often an early form of diabetic retinopathy that causes significant vision loss.  Almost all Type 1 diabetics and more than 60% of Type 2 diabetics will develop retinopathy. 

"There is no effective daily drug treatment for diabetic retinopathy other than general measures, such as controlling blood sugar, hypertension, blood lipids, etc.  Due to the global diabetes epidemic, diabetic retinopathy is recognized as a high unmet medical need that would benefit from having oral therapeutic options available. The only treatments available for macular edema now are laser therapy, injection or implantation of drugs into or around the eyeball (not approved in the US or Canada). To our knowledge, Optina™ is the only proposed oral treatment for this condition."

About Optina™
Ampio is developing Optina™, an orally administered ultra low dose of danazol, for the treatment of diabetic macular edema (DME).  Ampio's Chief Scientific Officer discovered an unexpected activity in his investigation of the mechanism of action of danazol: very low doses reversed inflammation induced increases in the permeability of blood vessels, thus reducing vascular leakage.  Dr. Bar-Or subsequently managed in-vitro studies that suggested this effect may reduce the vasogenic edema produced by various vascular le
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SOURCE Ampio Pharmaceuticals, Inc.
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