Analysis Of Available Data From Optimeyes Study (Blinded And Open Label) Of Optina™ For The Treatment Of Diabetic Macular Edema (DME) Indicates Potential For Significant Clinical Benefit
ENGLEWOOD, Colo., Aug. 20, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that in response to requests from patients and physicians, the company has performed an analysis of the available data from both portions of the study. On October 7, 2013, following an IDRC determination "that there was a treatment dosage (of OptinaTM) that was demonstrating a potentially beneficial anatomic effect." The company initiated an open label extension study using the IRDC chosen optimum dose of OptinaTM for all patients who have completed the trial and wished to continue treatment for an additional 12 weeks. On June 25, 2014 Ampio announced that it closed enrollment in the OptimEyes 505(b)2 clinical trial and was continuing analysis of the data available to seek further FDA guidance on the appropriate regulatory path.
Vaughan Clift, Ampio's Chief Regulatory Officer explained "The OptimEyes study included 359 patients with DME and 432 eyes were evaluated (some patients had more than one eye involved in the study). The average age of the treated patients was 63.5(10.25) and 55% of patients (n=198) were refractory to anti-VGEF intra-ocular therapy (no longer showing improvement or responding to treatment).
"The data of the blinded OptimEyes study is still "masked", pending the completion of the 12 weeks period for several patients, but valuable insight can be obtained by looking at the two portions of the study without unblinding it."
"From the open label portion where every patient received OptinaTM and the blinded portion, where one third received placebo and two thirds received one or the two doses of OptinaTM the following information can be determined:
- Overall, from baseline to the end of the open label period, 72% of patients saw improvements or stabilizations in their vision as measured by Best Corrected Visual Acuity (BCVA,
- Mean BCVA increased significantly, p<0.0001)after adjusting for baseline values
- 62% saw improvements in central retinal thickness as measured by Optical Coherence Tomography (OCT).
- Mean OCT decreased significantly, p<0.0001) after adjusting for baseline values.
"From a review of the double-blind portion of the study separately, the following information can be determined:
- 70% and 58% of patients saw improvements or stabilizations in their BCVA and OCT respectively.
- There were significant increases in BCVA (p=0.0003) and decreases in OCT (p=0.002), after adjusting for baseline values, during this time period.
Mr. Macaluso, Ampio's Chairman and CEO, stated: "With this encouraging data in hand and after discussions with the clinical investigator ophthalmologists who participated in the trial, and being well aware of the serious nature of this disease and the limited treatment options for patients, we are going to request the FDA allow us to unmask the trial, complete the analysis and present all the data."
OptinaTM, the ultra-low dose danazol, is an oral therapy with few side effects that may delay the relentless progression to blindness in patients with Diabetic Macula 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. If Optina demonstrated any efficacy it could be an invaluable addition to existing therapies particularly in those patients no longer responding to the approved drugs.
About OptimEyes Study
Conducted in 22 US Sites, this study was designed to explore the potential benefits of administering oral Optina to patients diagnosed with Diabetic Macular Edema. The primary end point was Best Corrected Visual Acuity, (BCVA) and a secondary endpoint of Ocular Coherence Tomography. (OCT) Once the patients completed the 12 week "masked placebo controlled" trial, there was a 4 week wash out period, then patients could volunteer for an open label extension and receive only the active dose of OptinaTM.
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 "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to the completion, timing and size of the registered direct offering, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. 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.
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SOURCE Ampio Pharmaceuticals, Inc.