FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema

Published on January 22, 2013 at 6:13 AM · No Comments

Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE) 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.

Michael Macaluso , Chairman and CEO of Ampio, commented "Having an active IND for Optina™ is an important milestone in the advancement of our lead compounds from our pipeline. This is a significant step in the approval process through an agreed upon 505(b)(2) pathway with the FDA. DME is a devastating complication of diabetes and we believe, based on a previous phase 2 study performed in Canada and extensive in vitro data, that Optina™ has the potential to become a valuable treatment option for DME. "

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