Validating Studies with EYS606
EYS606 is a novel non-viral gene therapy approach that was developed for the treatment of chronic non-infectious uveitis (CNIU). CNIU, which meets the criteria for a rare disease (affecting 250,000 patients in North America and Europe), is a sight-threatening immune-mediated inflammatory disease that causes inflammation in the eye that can lead to severely reduced vision or blindness resulting from ocular tissue damage. Uveitis affects people of all ages and may be triggered by another underlying condition.
The therapy has been used to validate the Eyevensys Electrotransfection System for safety and feasibility in two clinical trial studies across Europe and the U.S. with ongoing follow-up. As a result of data gathered in both studies, Eyevensys’ proprietary technology has been shown safe and the drug delivery method has been proven to be successful. The final design of the device will leverage data gathered during these studies.
People with chronic non-infectious uveitis in the US
Uveitis can be classified as anterior, intermediate, posterior, or panuveitis, on the basis of the part of the eye that is affected. Patients with CNIU commonly have uveitis involving the back of the eye (intermediate, posterior, and panuveitis), placing them at higher risk for vision loss due to disease exacerbations and complications of intraocular inflammation.
Current treatment options for CNIU include corticosteroids (systemic or injections in or around the eye), systemic immunosuppressants, or biologics such as systemic tumor necrosis factor (TNF) inhibitors. These standard-of-care treatments can have considerable side effects, particularly when used long term. Hence, there is a strong need for more convenient, safer, and effective treatment options for patients with CNIU.
EYS606 combines plasmids encoding a potent fusion protein that neutralizes the activity of TNF-α and the proprietary Eyevensys Electrotransfection System used to introduce the plasmids into the eye. TNF is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in CNIU.
EYS606 has already received orphan designation in Europe and is being investigated in 2 ongoing clinical trials enrolling patients with CNIU. Early results from these trials reveal no serious safety concerns and suggest that the treatment effect may persist for more than 6 months after a single administration.
EYS606 is currently available for licensing.
EYS606-CT2 Trial (US)
The Electro Study (NCT03308045) was a phase 2 clinical trial designed to compare the safety of 2 EYS606 treatment regimens in patients with all subtypes of active CNIU. The study enrolled patients at up to 10 US clinical trial sites. After an initial safety cohort, patients were randomly assigned to 1 of 2 treatment arms, to receive 1 or 2 doses of EYS606. All patients were followed up for 48 weeks, with the possibility of retreatment, if needed.
EYS606-CT1 Trial (EU)
The EYS606-CT1 study (NCT03308045; EUDRACT number: 2015-001391-22) was a phase 1/2 study assessing the safety and tolerability of EYS606 in patients with CNIU being conducted in Europe. Part 1 consecutively assigned patients with end-stage CNIU to 1 of 3 escalating EYS606 doses.
In part 2, patients with active CNIU received the maximally tolerated dose determined in part 1. After administration of EYS606, treated patients were assessed for safety, tolerability, and signals of efficacy for 48 weeks, with the possibility of retreatment, if needed.