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news.Santen has received orphan drug status for sirolimus (DE-109) from the European Commission (EC) as a treatment for chronic non-infectious uveitis.
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Sirolimus is currently being evaluated in a Phase III study entitled ‘study assessing double-masked uveitis treatment’ (Sakura) to evaluate the safety and efficacy of different doses of sirolimus.
The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) in June.
Santen, the US subsidiary of Japan-based global ophthalmic pharmaceutical company Santen Pharmaceutical, develops and markets ophthalmic products worldwide.