Vall d'Hebron Research Institute and BCN Peptides study efficacy of single-dose eye drops for diabetic retinopathy
The Europe-wide trial is using an eye drop developed by a Catalan company to prevent retinal neurodegeneration for the first time.
By Biocat
The Vall d'Hebron Research Institute (VHIR) in Barcelona is leading Europe-wide phase II and III clinical trials on a non-invasive treatment for diabetic retinopathy, a disease that affects approximately 30% of the diabetic population and can lead to blindness. The trial will assess the safety and efficacy in patients of a single-dose eye drop based on two neuroprotective drugs: somatostatin, a peptide hormone presented in a new formula (eye drops) and patented by biopharmaceutical firm BCN Peptides, and brimonidine, which is currently used to treat glaucoma. The phase I clinical trials were conducted in 2011 and 2012.
These studies are funded through the Eurocondor project, with €6 millions from the European Union’s 7th Framework Program (7FP), and will last through February 2016. Dr. Rafael Simó, director of the VHIR Diabetes and Metabolism Research Group, is coordinating the whole project, which includes 17 hospitals, universities and research centers from eight European countries and the company BCN Peptides. Simó and a group of experts (ophthalmologists, endocrinologists and basic researchers) from 11 clinical centers and BCN Peptides will conduct this groundbreaking clinical trial over the coming two years.
Rafael Simó: "We’re sure that the drugs we’re studying will be a turning point in the clinical treatment of these patients"
From the first somatostatin studies carried out by the VHIR Diabetes and Metabolism Research Group, there has been growing evidence to suggest that retinal neurodegeneration plays an important role in the onset of diabetic retinopathy. In fact, the study aims to prove that diabetic retinopathy is a neurodegenerative disease. With this in mind, the Eurocondor project will conduct phase II and III clinical trials to assess whether neuroprotective therapeutic strategies are effective in not only preventing retinal neurodegeneration but also preventing the onset and progression of early-stage diabetic retinopathy.
"Until recently, eye drops weren’t considered an adequate way to administer drugs to treat diabetic retinopathy, but recent studies show that many drugs administered this way can reach the retina in effective concentrations. Thus, based on experimental and safety trials, we’re sure that the drugs we are studying will be a turning point in the clinical treatment of these patients," says Dr. Rafael Simó.
The results of the Eurocondor project could have a considerable impact on preventing diabetic retinopathy, making retinal neurodegeneration a new therapeutic target. Moreover, explains Dr. Simó, “the methods used in this project will allow us to diagnose diabetic retinopathy in the early stages and could change current early-detection methods for this disease.”
The end goal of the project is to obtain authorization to market the product around Europe.
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