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Ampio Pharmaceuticals, Inc. Message Board

  • boatgas1 boatgas1 Jul 23, 2012 9:44 PM Flag

    Ampio: More than meets the eye (1)

    Following editorial taken from RTTnews:
    Diabetic macular edema, or DME, which is the major cause of vision loss in people with diabetic retinopathy, is estimated to affect approximately one million people in the U.S. alone. There is currently no oral drug approved by the FDA for the treatment of DME in the U.S. Working on the development of an oral drug for the treatment of diabetic macular edema is Colorado-based Ampio Pharmaceuticals Inc.
    For readers who are new to Ampio Pharma, here's a brief overview of the company's pipeline and the upcoming events to watch out for...
    Ampio Pharma's proposed oral treatment for diabetic macular edema - Optina, an ultra low dose of Danazol, has successfully completed phase II testing. Danazol, a derivative of synthetic steroid ethisterone, at high doses is an FDA-approved treatment for endometriosis, fibrocystic breast disease, hereditary angioedema and idiopathic thrombocytopenic purpura.
    As a next step, Ampio Pharma is scheduled to meet with the FDA at the end of this month (July), and discuss the design of a pivotal trial in the US under the 505(b)(2) regulation and clarify the path for approval for Optina. The company is currently in discussions with potential partners to co-develop Optina for DME.
    Optina has been issued and allowed method of use patents in the U.S., EU, Canada and Hong Kong.
    It is estimated that about 14 percent of diabetics have DME. In the U.S., the only approved treatment for DME is laser therapy. The FDA-approved wet AMD treatment Lucentis injection of Roche Group's Genentech is under FDA review as a potential treatment for DME. Last year, Lucentis was approved for treatment of visual impairment due to DME in Europe.

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