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Ampio Awarded US and Canadian Patents that will Bolster the Commercialization of Optina™ for the treatment of Diabetic Macular Edema (DME)
Date:4/27/2012

e 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™
Optina™ is 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 leak syndromes, including diabetic macular edema (DME) which can impair vision and cause blindness. The specific Optina dosages used in the trial are proprietary and subject to multiple patent filings.

Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema, ITP and fibrocystic disease of the breast.

About Ampio
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfun
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SOURCE Ampio Pharmaceuticals, Inc.
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