The Company’s Lead Product is a soluble TNFalpha receptor plasmid associated with the ETIS device, and it addresses a range of ophthalmological diseases involving inflammatory components, such as Non-Infectious Uveitis.
The Company expects the clinical development programme of EYS606 to follow a fast development track, considering that the most severe forms (PSII) is an orphan disease. EYS606 received orphan drug designation in Europe in January 2016. An ODD filing in the USA is underway.
The product has been approved in February 2017 by MHRA and MHRA
Devices in the UK, and ANSM in France. The Company is starting a multicentre Phase I clinical
trial in both countries.
The objectives of the Phase I Clinical Trial are two-fold:
• Establish the feasibility and safety of therapeutic plasmid electroporation in humans;
• Achieve clinical efficacy proof of concept of sustained protein delivery in the eye, in the NIU indication.