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.
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