ENGLEWOOD, Colo., Jan. 11, 2016 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that the
Abstract titled: "Potential Beneficial Effect of Low Dose
Danazol in Combination With Renin Angiotensin System Inhibitors in
Diabetic Macular Edema: a 12-week Multicenter Double-Blind
Randomized Controlled Trial" was accepted by the World
Ophthalmology Conference (WOC 2016) for presentation at the Late
Breaking News Session.
Dr. Michael Singer, a Retina,
Macular Degeneration and Diabetic Eye Specialist, Vitreoretinal
Surgeon and Associate Professor of Ophthalmology at University of Texas Health Sciences Center and
Principal Investigator of the OptimEyes Study will present the data
on February 7, 2016.
Dr. Vaughn Clift, Ampio's Chief
Medical Officer, explained, "The WOC reviewers chose a small number
of submitted abstracts as "late-breaking news," with the
intention of highlighting "novel, substantive, and high-impact
studies" by featuring oral presentations. The 12-week
multi-center, placebo-controlled, double-masked randomized trial
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."
About the WOC
The World Ophthalmology Congress® (WOC) of the
International Council of Ophthalmology is the longest continuous
international medical meeting, first held in 1857. The
WOC2014 took place on April 2-6, 2014
in Tokyo, Japan. Held every two
years, the next WOC will take place in February 2016 in Guadalajara, Mexico.
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 Optina
OptinaTM (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,
OptinaTM 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.
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 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
OptinaTM and its affects, 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
OptinaTM 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.
Investor Contact
Gregory A.
Gould
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6513
Email: ggould@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.