logo
Share SHARE
FONT-SIZE Plus   Neg

Amended: Ampio Pharma Says FDA Accepts IND For Diabetic Macular Edema Drug

Corrects Headline & 1st Para to Indicate FDA Accepts IND for Eye Drug

Ampio Pharmaceuticals, Inc. (AMPE) Tuesday 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.

The planned multi-center trial, scheduled to begin in the first quarter, is designed to evaluate the safety and efficacy of oral Optina compared with placebo given over a period of 12 weeks in adult patients with DME.

Patients will be randomized to receive one of two doses of Optina per day or placebo. Interim analysis will occur after patients have completed 4 weeks of initial treatment.

Following the 12 week active treatment period, there will be a further 4 week washout period to determine regression of treatment effect.

The primary endpoint is improvement in visual acuity, defined by responder status, compared to placebo, while secondary endpoints include measurements of changes in VA and central macular thickness, tolerability etc.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Bank of Nova Scotia or otherwise known as Scotiabank, Friday reported lower net profit for the third quarter, in the absence of a year-ago gain. Earnings per share, however, came in line with the Street view. Further, the company said it raised its quarterly dividend by 2 cents. Non-traditional discount and variety stores operator Big Lots Inc. (BIG) Friday reported a decline in net profit for the second quarter, while net sales grew 1.2 percent from the prior year. Comparable sales for the quarter increased 2.8 percent. Google has rejected the European Union's charges that it abused its market power and the demanded that it change the way it ranks online comparison shopping services in its search results, setting up a potentially long legal battle with the EU regulator empowered to levy billions of euros in fines
comments powered by Disqus
Follow RTT