Orphan Drugs

The European Medicines Agency’s (EMA) has defined Orphan Drugs as follows

A medicinal product is designated as an orphan medicinal product if:

The European Medicines Agency’s (EMA) has granted Gene Signal four Orphan Drug designations in Ophthalmology

The following Orphan Drug designations were granted to Gene Signal for aganirsen (GS 101) antisense oligonucleotide:

On 11 June 2014, Orphan designation (EU/3/14/1275)  was granted by the European Commission to Gene Signal for aganirsen (GS-101) for the treatment of Central Retinal Vein Occlusion, the most common cause of Neovascular Glaucoma. 

On 17 April 2007, Orphan designation (EU/3/07/445) was granted by the European Commission to Gene Signal for GS-101 for the prevention of Corneal Graft Rejection 

On October 2nd 2003, Orphan designation (EU/3/03/161) was granted by the European Commission to Gene Signal for GS-101 for the treatment of Neovascular Glaucoma

On October 2nd 2003, Orphan designation (EU/3/03/160) was granted by the European Commission to Gene Signal for GS-101 for the treatment of Retinopathy of Prematurity