Eyevensys Receives Orphan Drug Designation in the European Union for EYS606 for the Non-Infectious Uveitis (NIU)
Paris, 18th February 2016 – Eyevensys, an IND-stage biotechnology company developing non-viral gene therapies in the eye, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to EYS606 for the treatment of refractory NIU, ahead of the upcoming Phase I study planned to start later this year.
“We’re pleased to announce that EMA’s Committee for Orphan Medicinal Products has issued on the 21st of January 2016 a positive opinion on orphan designation for EYS606 in the treatment of non-infectious uveitis. This confirms the potential of the Ciliary Electro-Transfection technology to offer patients suffering from severe ophthalmic diseases an enduring therapeutic solution”, said Raffy Kazandjian, CEO of Eyevensys.
Orphan Drug Designation in the European Union (EU) is granted to drugs or biologics that treat a life-threatening or chronically debilitating rare disease affecting fewer than five in 10,000 individuals. Products receiving orphan drug designation are eligible to receive market exclusivity for a period of up to ten years, as well as development incentives such as regulatory and protocol assistance.
“Our clinical program, due to commence second quarter of this year, in refractory NIU, will greatly benefit as a result of this designation, and several reputed Centres across Europe have expressed their keenness to participate in the upcoming clinical trial”, says Professor Francine Behar-Cohen (Chief Medical Director of the Gonin Ophthalmic Hospital in Lausanne, and Director of Inserm Team “From physiopathology of retinal diseases to clinical developments”, at Cordeliers Research Centre (Inserm/UPMC/Paris Descartes University Unit 1138, Paris), the scientific founder behind this novel concept.
About NIU Uveitis, which often has an autoimmune component, is the inflammation of the uvea, the pigmented layer that lies between the inner retina and the outer fibrous layer composed of the sclera and cornea. The most frequent aetiologies are autoimmune diseases such as Behçet disease. Non-infectious intermediate and posterior uveitis (NIU) represents 10%-15% of uveitis cases, and is the 4th cause of blindness, affects about 250,000 patients in North America and Europe.
About EYS606 EYS606 is a combination product and method consisting of a plasmid, encoding for a soluble TNF receptor, associated to a high precision electro-transfection-injection system (ETIS). EYS606 demonstrated high efficacy and long lasting effects in a number of different animal models. The technique leads to the sustained expression of therapeutic agents in ocular media over extended periods, alleviating the pain of repeated invasive administrations. EYS606 also displayed a remarkable level of safety in GLP toxicity studies. Eyevensys aims at starting a multi-centre European clinical trial in NIU during 2016, in up to 7 centres in France, UK, and other European centres.