Eyevensys, a private biotechnology company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces it has received approval from the French product security regulatory agency “Agence Nationale de Sécurité du Médicament” (ANSM) to advance its technology into clinical development.
The EyeCET platform uses Eyevensys’ proprietary electro-transfection injection system (ETIS) to deliver plasmids that encode for the production of disease-specific therapeutic proteins in the ciliary muscle of the eye. Eyevensys’ lead product, EYS606 uses a plasmid encoding for the production of anti-TNFα for the treatment of Non-infectious Uveitis (NIU). EYS606 has been granted an Orphan drug designation by the EMA for the treatment of NIU.
Raffy Kazandjian, CEO of Eyevensys, said: “This clearance from the ANSM is a landmark achievement for Eyevensys given the unique features of EYS606, which combines an anti-TNFα plasmid with a novel and unique medical device, designed to carry out an electroporation procedure. We are now in a position to demonstrate that our EyeCET technology can provide ophthalmology patients with much needed and improved treatment options. We plan to start our first Phase I trial with EYS606 shortly.“