Charlesson, LLC — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant This Small Business Innovation Research project aims to develop an innovative eye drop formulation for the treatment of diabetic retinopathy The goal of this proposal is to develop substantial efficacy safety and pharmacokinetic data to support the clinical development of topical fenofibrate We hypothesize that topical application of fenofibrate can reduce vision loss and neovascularization in animal models of diabetes and retinal disease The goal of this proposal is to evaluate the efficacy of topical fenofibrate on preventing visual acuity loss in a rat model of streptozotocin induced diabetes We will give fenofibrate eye drops either two or four times a day for weeks We will measure the change of visual acuity over this time period The long term goal Phase is to perform safety studies and find a commercial manufacturer for the formulation PUBLIC HEALTH RELEVANCE Nearly all patients with type diabetes and andgt of type diabetic patients will develop some form of retinopathy and visual loss in their lifetime Fenofibrate is a peroxisome proliferator activated receptor alpha PPAR agonist that has been shown in both The Fenofibrate Intervention and Event Lowering in Diabetes FIELD and The Action to Control Cardiovascular Risk in Diabetes ACCORD clinical trials to reduce the progression of diabetic retinopathy in diabetic patients Oral fenofibrate appears to have limited systemic benefit in diabetic patients thus the topical application of fenofibrate for diabetic eye disease represents a more targeted and safe approach to treat diabetic retinopathy