Novartis Receives CDE Approval for Lifitegrast Ophthalmic Solution Clinical Trial in China for Dry Eye Disease

On March 16, the latest announcement on the CDE official website showed that the clinical trial application of lifitegrast ophthalmic solution submitted by Novartis has obtained tacit approval. It is intended to be used for treating the signs and symptoms of dry eye. Public information indicated that this drug is the first prescription drug approved for treating the signs and symptoms of dry eye by inhibiting inflammation caused by dry eye.

Previously, lifitegrast ophthalmic solution has been approved in multiple countries and regions including the United States, Canada, and Australia for the treatment of eye damage caused by dry eye disease and alleviation of its symptoms. In 2019, Novartis reached an agreement with Takeda to acquire the drug for up to $5.3 billion.

Lifitegrast Ophthalmic Solution: The main component is 5.0% concentration of lifitegrast. It inhibits the binding of LFA-1 to ICAM-1, thereby reducing inflammation levels mediated by T lymphocytes. According to an earlier press release from Novartis, lifitegrast ophthalmic solution not only treats eye damage caused by dry eye disease but also alleviates its associated discomfort symptoms. It is the first prescription drug approved for treating the signs and symptoms of dry eye disease by inhibiting inflammation caused by the condition. Phase 3 clinical trials have shown that this new drug acts quickly and has good safety and tolerability.

(Source: CDE official website, Pharmaceutical Observer)