FDA authorizes Sylentis (PharmaMar Group) to initiate Phase III trial with tivanisiran for the treatment of dry eye disease

This Phase III study, called SYL1001_V, will involve more than 30 hospitals in the United States. It will evaluate the efficacy and safety of tivanisiran ophthalmic solution on the signs and symptoms of patients with dry eye disease associated with Sjögren’s Syndrome. The study has been approved by the FDA in 30 days and will be part of the marketing authorization application. Sylentis, a PharmaMar Group company (MSE:PHM), announced today that the US FDA (Food and Drug Administration) has authorized the initiation of the Phase III clinical trial SYL1001_V with tivanisiran ophthalmic solution (eye drops), for the treatment of dry eye disease associated with Sjögren’s Syndrome. The study design has been approved by the FDA in 30 days and will be part of the marketing authorization application, which will include another Phase III trial. In this study more than 30 hospitals in the United States and 200 patients. It is a randomized, double-masked, placebo-controlled study, the primary and secondary endpoints are, respectively, to evaluate the efficacy (signs and symptoms) and safety of tivanisiran in patients with dry eye disease, associated with Sjögren’s Syndrome. This Phase III will not be conducted in Spain. Tivanisiran represents a breakthrough in the development of innovative drugs in different therapeutic areas through gene silencing technology based on RNA interference (RNAi). It is a drug administered in eye drops for the control of inflammation and pain, characteristic of this pathology. Both the design of the protocol for this trial and its authorization by the regulatory authorities are based on the scientific evidence of safety and efficacy obtained in the Phase III HELIX trial. This study showed a significant improvement in signs and symptoms in the subgroup of patients with Sjögren’s syndrome, which is a more severe form of dry eye disease. Ana Isabel Jiménez, COO and head of R&D at Sylentis, said: “The initiation of this trial in the United States represents an important step towards advancing our goal of providing innovative therapies to patients with ocular surface diseases. The FDA has been very expeditious in clearing this study, giving us the go-ahead in just 30 days since we submitted it.” Explanatory videos: What is RNA interference? Dry Eye Disease

The release as fetched from its publisher. pharmamar.com ↗