ENGLEWOOD, Colo., October 4, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a manuscript titled: “Potential Beneficial Effect of Low Dose Danazol in Combination With Renin Angiotensin Inhibitors in Diabetic Macular Edema” was accepted for publication in Acta Ophthalmologica, an international peer-reviewed journal in the field of ophthalmology.
Ampio’s CSO, Dr. David Bar-Or, explained “The article, coauthored by Dr. Michael Singer, retinologist at the University of Texas, reports the clinical benefits of Optina™, from a 12-week multi-center, placebo-controlled, double-masked randomized trial which identified a reversal of pathological changes and a synergistic effect with other medication. As previously reported, oral treatment with Optina™ (low-dose danazol) has been shown to be safe and confer significant improvements in visual acuity (VA) and reductions in central retinal thickness (CRT) in patients with diabetic macular edema (DME) when given the optimal dose, in particular for patients on Renin Angiotensin Inhibitors.”
Dr. Singer, who previously presented the results of this trial at the World Congress of Ophthalmology and at The Association for Research in Vision and Ophthalmology (ARVO), also presented these findings recently at the 2016 annual meeting of the Retina Society held in San Diego, CA.
The mission of the Retina Society is to reduce worldwide visual disability and blindness by promoting the education and professional interaction of vitreoretinal specialists, providing optimal care for patients with vitreoretinal diseases, and encouraging, through clinical and basic research, the discovery and development of new means to further patient care.
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 area 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.
Optina™, (ultra-low dose danazol) is an oral therapy with few side effects that may delay the progression to blindness in patients with Diabetic Macular Edema (DME). DME is a component of Diabetic Retinopathy that damages the eye. Palliative laser therapy and anti-VGEF injections in the eye are the only approved therapies. For some fraction of the DME patients, Optina™ could be an invaluable addition to existing therapies particularly in those patients no longer responding to the approved drugs. http://ampiopharma.com/news/ampio-pharmaceuticals-announces-additional-statistically-significant-study-results-for-optina-in-the-treatment-of-diabetic-macular-edema-dme/
About Ampio Pharmaceuticals:
Ampio Pharmaceuticals, Inc. is a clinical trial 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.
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 “plan,” “continue”, “present,” “could,” “may,” “will be,” and similar expressions. These forward-looking statements include statements regarding Ampio’s plans with respect to the Optina™, and its effects, which are subject to the risks associated with clinical trials, regulatory approvals, and changes in business conditions and similar events. These risks include the uncertainty of the regulatory response to the sufficiency of trial data and trial design, that regulatory approval may not be obtained or delayed with respect to Optina™, and Ampio’s other products, and the risks and uncertainties 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
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6500