ENGLEWOOD, Colo., Jan. 26, 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 Association
for Research in Vision and Ophthalmology Conference (ARVO 2016) for
presentation. This acceptance and presentation are in addition to
the previously announced acceptance and presentation at the World
Ophthalmology Congress to be held in Guadalajara, Mexico. These two Meetings are
the largest and most prestigious ophthalmology meetings in the
world.
Dr. Michael Singer, a Retina,
Macular Degeneration and Diabetic Eye Specialist, Vitreoretinal
Surgeon, Associate Professor of Ophthalmology at University of Texas Health Sciences Center and
Principal Investigator of the OptimEyes Study will present the data
in May 2016 in Seattle, Washington.
Dr. Vaughn Clift, Ampio's Chief
Medical Officer, explained, "ARVO is the largest and most respected
eye and vision research organization in the world and will be held
this year from May 1st to
the 5th in Seattle, WA.
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, in
particular for patients on Renin Angiotensin Inhibitors."
About ARVO
ARVO is the largest and most respected eye and vision research
organization in the world. Members include nearly 12,000
researchers from over 75 countries. ARVO advances research
worldwide into understanding the visual system and preventing,
treating and curing its disorders.
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.
About Optina
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.
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
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.
Investor Contact
Gregory A. Gould
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6513
Email: ggould@ampiopharma.com
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