The European Medicines Agency (EMA) has not approved Xiidra (lifitegrast) for the treatment of dry eye disease in Europe. Xiidra is approved by the U.S. Food and Drug Administration (FDA) for this indication [1].
What is Xiidra used for?
Xiidra is a prescription eye drop used to treat the signs and symptoms of dry eye disease [1]. It works by blocking the action of a specific protein that contributes to inflammation associated with dry eye [1].
When did Xiidra get FDA approval?
Xiidra received FDA approval for the treatment of dry eye disease on July 11, 2016 [1].
Who manufactures Xiidra?
Shire, a Takeda company, manufactures Xiidra [1].
What are the potential side effects of Xiidra?
The most common side effect of Xiidra is eye irritation [1]. Other potential side effects include blurred vision, altered taste, and stinging or burning of the eyes [1].
Are there alternative treatments for dry eye disease in Europe?
In Europe, various treatments are available for dry eye disease, including artificial tears, prescription eye drops like cyclosporine, and punctal plugs. The EMA's regulatory decisions will determine the availability of specific medications within the European Union. Information on approved treatments can be found through national regulatory agencies and the EMA website.
What is the patent status of Xiidra?
Information regarding the patent status of Xiidra and any related litigation or exclusivity periods can be tracked through resources like DrugPatentWatch.com, which monitors global drug patents and market exclusivity [2].