Huons said Thursday that the German Federal Institute for Drugs and Medical Devices has approved phase 3 clinical trials of the company's nanocomposite eye drop, HU-007.
The clinical trial is to confirm HU-007's safety and efficacy of combined treatment with protective and anti-inflammatory effects in protecting tear film in patients with multifactorial dry eye syndrome. About 35 institutions in Germany will conduct the double-blinded, placebo-controlled clinical trials.
Huons’ nanocomposite eye drops are ophthalmic products that combine cyclosporine, which has anti-inflammatory properties, with trehalose, which protects eyes.
The company reduced the dose of the previously used cyclosporine by more than half and maintained equal effectiveness through nanoparticulation. HU-007 is also designed to improve dry eye symptoms by protecting tear film swiftly. Single drug of cyclosporine and hyaluronic acid is typical worldwide. Still, only cyclosporine has permissions in Europe as a single medication for dry eye syndrome.
Huons officials anticipate that the clinical trials in Europe will proceed smoothly, as HU-007 is in the final stages of phase 3 study in Korea and is likely to obtain the permit as a new drug this year.
"As the phase 3 clinical trial in Korea is going on without a hitch, we will also successfully conduct the study in Germany as well," Huons CEO Um Ki-ahn said. "Huons plans to expand to the European market by gaining marketing authorization via the European Union's centralized procedure after completing the clinical trial."
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