The university project “Ions of Skulachev” and “Mitotech” reported that Phase III clinical trial of ophthalmic drug Vizomitin had been launched in the United States. It was among the drugs that could reach the final phase of research in the United States. If the studies are successful, Vizomitin can be registered by the FDA.
The active ingredient of the drug is the mitochondria-targeted antioxidant SkQ1, which is able to penetrate into the mitochondria of living cells and protect them from oxidative damage. As a result, the drug has a mild anti-inflammatory effect and accelerates tissue regeneration.
About 500 patients with dry eye syndrome will take part in the multicenter study. The main task of the study is to confirm the previously obtained data that SkQ1 accelerates the healing of corneal injuries occuring at dry eye syndrome, as well as eliminates the clinical manifestations of the disease and increases the resistance of the eyes to dry air.
The latter parameter will be estimated with the special system Ora CAE® (controlled unfavorable environment). Its use allows to simulate the stress conditions in a standardized way where a patient with “dry eye syndrome” periodically falls.
According to Maxim Skulachev, the CEO of Mitotech, the results of a clinical trial will be obtained in the latter half of 2019. “Thus, the first Russian medicine can be launched on the US market already in 2020-2021,” he said.