Ampio Pharma Says FDA Accepts IND For Diabetic Macular Edema Drug
Ampio Pharmaceuticals, Inc. said the FDA has accepted its IND for Optina, an oral drug used in the treatment of diabetic macular edema, or DME. Optina had been given 505-b-2 status by FDA in July, 2012. Drugs designated under this pathway can be approved on a single trial. DME is a devastating complication of diabetes and is manifested by local and systemic inflammation. Optina also has the potential to treat other systemic complications of diabetes such as nephropathy, said the company.