Ampio up 28% premarket on selected Optina study results

• Micro cap Ampio Pharmaceuticals (NYSE:AMPE) is up 28% premarket on robust volume in response to its announcement of positive results from a Phase 3 study, OptimEyes, assessing orally administered Optina (danazol) in 355 adult patients with diabetic macular edema (DME).
• 53% (n=188/355) of trial participants were unresponsive (refractory) to intraocular injection therapy. This group showed a +6.2 letter improvement in visual acuity over the three-month study period (p<0.001). In the remaining 47% (n=167/355), participants who were unable or unwilling to have eye injections (n = unknown) showed a +3.1 letter improvement over the same period (p=0.04). The placebo arm, as expected, failed to demonstrate a significant increase in visual acuity.
• The company neglects to disclose the results for the entire trial (n=355) or the 47% segment (n=167).
• Ampio plans to continue its analysis and present the data to the FDA. After receiving guidance, it will disclose more detailed information. Translation: the study, in its totality, failed to achieve its efficacy endpoint.