Ampio Pharmaceuticals, in Response to Positive Feedback, Closes Enrollment in the OptimEyes Study (Optina™) and Will Present the Data to the FDA for Guidance
GREENWOOD VILLAGE, Colo., June 25, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE) today announced that it has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes Study for the treatment of Diabetic Macular Edema (oral treatment with Optina"). This trial was intended to enroll 450 patients and was powered at 95%. The present enrollment of over 355 patients provides an adequate power of 88%, which the company believes is more than sufficient for statistical evaluation.
"There have been anecdotal reports from several principal investigators that OptinaTM may be providing benefit to patients," said Dr. Vaughan Clift, Chief Medical Officer. "The decision to reduce the sample size of the trial took into consideration requests from these site investigators, asking to extend the open label enrollment portion (where all patients receive active drug dose) of the trial beyond the 12 weeks allowed for in the protocol. These clinicians believed that their patients were improving while on the active drug and subsequently regressed quickly once they completed the open label phase. The enrollment in the open label extension phase was much higher than expected. Since DME is a very serious and progressive condition that often leads to blindness, the company believes it is in the patient's best interest to analyze the data as soon as possible to confirm any observed benefits. By reducing the patient sample size, we can expect data by Q4, 2014."
About the "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 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 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.
Ampio Pharmaceuticals, Inc.
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