Ampio Announces Update on the Optina™ Clinical Trial, Decision to Conclude the Study Ahead of Schedule
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Company will request a meeting with FDA in order to initiate U.S. registration studies.
Ampio Pharmaceuticals, Inc., a biopharmaceutical company conducting clinical trials on its three lead drugs (Zertane™ completed two phase III studies, Ampion™-completed proof of concept studies and Optina™), licensing distribution of these drugs and engaged in further drug development, today announced that it completed the planned interim review of the first 50% of patients enrolled in the Optina™ trial for diabetic macular edema.
Conducted at St. Michael Hospital in Toronto Canada, the trial explored the safety and efficacy of twice-daily oral doses of Optina™, to reduce macular edema as determined by OCT (optical coherence tomography). OCT is a measure of the thickness of the macula, the area of the retina responsible for color and sharp vision. Macular edema, or swelling of that part of the retina, is a common consequence of diabetes and is the first step in the development of diabetic blindness.
According to Dr. Vaughan Clift, Chief Regulatory Officer of Ampio, "A preliminary assessment, of the primary end point (OCT) indicates a beneficial and consistent effect with the ultra-low dose of Optina™ at 4 and 12 weeks of treatment and no apparent benefit at the high dose. These preliminary results are in keeping with the in-vitro data, which demonstrated a biphasic effect of the drug (effective in reducing vascular permeability at very low doses and cessation of these beneficial effects at the higher doses, which are used clinically for other approved indications)."
Dr. Clift continued, "Based on these positive and encouraging results and the potential of lack of efficacy at the higher doses, both doses being present in this study, Ampio decided to conclude this study ahead of schedule and to proceed with the preparation of a consultation package for the FDA that includes the basic science and clinical results for discussion of the design of a pivotal trial in the US under the 505(b)2 regulation for repurposed drugs. A detailed analysis of the study results will follow pending the completion of data analysis by our CRO."
