Michael Macaluso, Ampio's CEO, stated: "We are planning, in consultation with retinologists and the FDA, to explore the therapeutic potential of Ampion™ eye drops as stand-alone treatment, or in conjunction with Optina™ or other anti-VEGF drugs, in treating these deteriorating eyesight conditions as well as exploring the anti-inflammatory properties of these eye drops for treating "dry eye" syndrome. We are preparing our manufacturing facility to produce these eye drops in specialized eyedropper containers for delivery into the eye."
About Neovascular (wet) AMD
AMD is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small spot near the center of the retina and the part of the eye needed for sharp, central vision, which lets us see objects that are straight ahead. In neovascular AMD (also called wet AMD), abnormal blood vessels grow underneath the retina that can leak fluid and blood, which may lead to swelling and damage of the macula. The damage may be rapid and severe, unlike the more gradual course of geographic atrophy. It is possible to have both geographic atrophy and neovascular AMD in the same eye, and either condition can appear first.
About Diabetic Macular Edema (DME)
Type 1 and type-2 diabetes mellitus affects 26 million people in the United States. One of the many symptoms of diabetes is the local and systemic inflammation of the microvascular system. Diabetic retinopathy is a complication of diabetes and is characterized by damage to the blood vessels of the retina and can either be proliferative or non-proliferative. Proliferative damage occurs when a reduction in oxygen levels in the retina due to impaired glucose metabolism causes fragile blood vessels to grow in the vitreous humor. Non-proliferative damage occurs when existing vessels experience poor endothelial cell linkage due to increased blood glucose levels and hypertension. Macular edema is the most common form of non-proliferative diabetic retinopathy. In diabetic macular edema, prolonged hyperglycemia compromises endothelial cell linkage leading to vascular permeability. The leakage of fluid, solutes, proteins and immune cells cause the macula to swell and thicken. This leads to damage of the central retinal tissue and can significantly impair sharp central vision. The prevalence of diabetes is 11.3% of the population above the age of 20, with an annual incidence of 1.9 million cases in the United States alone. In this population, the prevalence of diabetic macular edema is estimated at 30% of patients inflicted by the disease for 20 years or more.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process, and (iii) decreasing vascular permeability.
Forward Looking Statements
Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to planning to explore the therapeutic potential of Ampion™ eye drops as stand-alone treatment, or in conjunction with Optina™ or other anti-VEGF drugs, in treating these deteriorating eyesight conditions as well as exploring the anti-inflammatory properties of these eye drops for treating "dry eye" syndrome, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. These forward-looking statements also include statements regarding preparing our manufacturing facility to produce these eye drops in specialized eyedropper containers for delivery into the eye. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500
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SOURCE Ampio Pharmaceuticals, Inc.