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
Automakers on Tuesday reported mixed U.S. vehicle sales results for the month of May, which included the Memorial Day weekend but had one less selling day compared to the same month last year. General Motors Co. and FCA US, LLC each reported higher vehicle sales for the month, while Ford Motor Co. and Toyota Motor Corp. both reported declines. Internet service providers and subscription TV services companies, including cable and satellite TV, continue to disappoint with their services, according to a study conducted by the American Customer Satisfaction Index (ACSI). According to the study compiled by surveying over 14,000 customers covering... Buoyed by surging demand for its vehicles, Ford said it would shorten its summer shut-down at its assembly plants in North America.
comments powered by Disqus
RELATED NEWS
Trade AMPE now with 
Follow RTT