China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its market filing for the drug candidate SHR8058 has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is dry eye disease associated with meibomian gland dysfunction.
SHR8058: Mechanism and Development
SHR8058 is NOV03 (perfluorohexyl octane), a drug candidate in-licensed from Novaliq GmbH in 2019. It is designed to treat hyper-evaporative dry eye related to meibomian gland dysfunction by forming a stable envelope on the eye’s surface to prevent excessive tear evaporation. Currently, no product with a similar mechanism of action is available on the market in China, although Novaliq’s NovaTears has been approved as a medical device in the European Union and Australia.
Clinical Trial Results
A multi-center, randomized, double-blind, saline solution parallel-controlled Phase III study previously assessed the efficacy and safety of SHR8058 in dry eye disease associated with meibomian gland dysfunction. The study reached pre-set priority standards in November 2021. Results showed that SHR8058 significantly improved the symptoms and signs of dry eye disease compared to a placebo. Additionally, SHR8058 demonstrated safety and reliability, with good local tolerance and an incidence of local sensory abnormalities equivalent to that of a placebo.-Fineline Info & Tech
