Ampio initiates clinical trial of Optina in DME, first patient dosed Ampio Pharmaceuticals announced oral dosing of the first patient in a 505b2 clinical trial of the investigational drug Optina in diabetic macular edema, or DME. The trial will evaluate Optina in adults with recent onset diabetic macular edema. Last year, the FDA granted Optina 505b2 status and drugs designated under this pathway can be approved on a single trial.
Ampio says Optina benefit not significant vs. placebo, Bloomberg reports Vaughan Lennox Clift, Chief Regulatory Affairs Officer of Ampio, told Bloomberg in a phone interview that Optina's benefit is not significant versus the placebo. Optina helped a group improve from baseline, Bloomberg adds. Clift also said the FDA may allow narrow sales with a post-market study.