Santen, a global pharmaceutical company specialised in the fields of ophthalmology, has announced that a European Marketing Authorization Application (MAA) for Ikervis® has been filed to the European Medicines Agency (EMA) for the treatment of Dry Eye disease.
In doing so, the EMA will begin its regulatory review process of the MAA. The application includes safety and efficacy data from Ikervis®’s clinical program which was conducted in Europe.
The filing of the application for Ikervis® to the European Medicines Agency is an important step forward in the development of the Santen’s Dry Eye franchise.
Founded in 1890, Santen is a global pharmaceutical company specialised in the fields of ophthalmology and ant-rheumatics, which is headquartered in Osaka, Japan. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide. Santen has subsidiaries in the US, Europe, and Asia, including its Emeryville, California based Santen Inc., its Tampere, Finland based Santen OY, its Evry, France based Santen SAS and Novagali Innovation Center, its Suzhou, China based Santen Pharmaceutical (China) Co, Ltd. and its Bangalore, India based Santen India Private Limited.