Positive update on Ampio oral eye drug Optina

Colorado, USA-based biopharma firm Ampio Pharmaceuticals,(Nasdaq: AMPE) yesterday announced that it completed the planned interim review of the first 50% of patients enrolled in the trial of Optina, an orally administered ultra low dose of danazol, for the treatment of diabetic macular edema with positive findings.

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). 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.
Ampio’s shares rocketed 37% to $3.67 in morning trade on the Nasdaw on Monday, after touching a two-month high of $4.40 in early trading, according to a Reuters report.

According to 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)."