Orphan designation: Tranilast Prevention of scarring post glaucoma filtration surgery, 27/07/2010 Positive
At the time of designation, the number of patients at risk of scarring post glaucoma filtration surgery was estimated to be less than 3 in 10,000 people in the European Union (EU)*. This is equivalent to a total of fewer than 152,000 people, and is below the threshold for orphan designation, which is 5 people in 10,000. This is based on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).
*Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed on the basis of data from the European Union (EU 27), Norway, Iceland and Liechtenstein. This represents a population of 506,500,000 (Eurostat 2010).
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