EYS606 is a novel non-viral gene therapy approach being 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.
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-CT1 Trial (EU)
In part 2, currently ongoing, patients with active CNIU will receive the maximally tolerated dose determined in part 1. After administration of EYS606, treated patients will be assessed for safety, tolerability, and signals of efficacy for 48 weeks, with the possibility of retreatment, if needed.
The EYS606-CT1 study (NCT03308045; EUDRACT number: 2015-001391-22) is a phase 1/2 study assessing the safety and tolerability of EYS606 in patients with CNIU being conducted in Europe. Part 1 will consecutively assign patients with end-stage CNIU to 1 of 3 escalating EYS606 doses.