FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema
Ampio Pharmaceuticals, Inc. announced today that the FDA has accepted the Company's IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved on a single trial.