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Ronald BUGGAGE, Francine F Behar-Cohen; EYS606 for the Treatment of Chronic Non-Infectious Uveitis (NIU): Results from Part 1 of a First-in-Human (EYS606-CT1) study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):3170.
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EYS606 is a non-viral gene therapy administered using the Eyevensys electrotransfection system that induces the ciliary muscle to express a potent tumor necrosis factor-alpha (TNFα) fusion protein in the eye. Herein, we present results from Part 1 of the EYS606-CT1 study that provides evidence for the safety, potential efficacy and duration of effect of EYS606 in patients with chronic non-infectious uveitis.
EYS606-CT1 is a two-part, 24-week multicenter, open-label, first-in-human phase I/II study investigating the safety and tolerability EYS606. In recently completed dose escalation phase of the study (Part 1), patients with end stage uveitis patients were assigned to treatment with one of three escalating EYS606 doses. In the ongoing extension phase of the study (Part 2), patients with active, chronic NIU receive one administration of the highest and maximally tolerated EYS606 dose (135mg plasmid/90ml).
9 patients (3 per cohort) with refractory posterior or panuveitis were treated with EYS606 in Part 1 of the study. The most commons adverse events following EYS606 treatment (conjunctival hemorrhage, foreign body sensation, conjunctival tears, keratitis, epithelial defects and transient visual loss) were mostly mild in severity and related to the administration procedure. Signs of efficacy observed in 3 of the 9 treated patients include a ≥ 10 letter gain in vision 2 weeks after treatment in one cohort 1 patient and a ≥ 20% reduction in macular edema associated with a ≥ 12 letter gain in vision in two cohort 3 patients. The improved vision in the two cohort 3 patients associated with normalization of the central retinal thickness on OCT occurred at 6 and 8 months following EYS606 treatment. Preliminary results from Part 2 will be presented.
Part 1 of the EYS606-CT1 study demonstrates the safety and potential efficacy of EYS606 in patients with chronic NIU and suggests that one administration at the highest dose of this novel non-viral gene therapy induces sustained anti-TNFα protein expression at therapeutic concentrations lasting longer than 6 months. The results from the ongoing Part 2 of the EYS606-CT1 study and the upcoming US Electro study evaluating different EYS606 regimens will further clarify the potential advantages of EYS606 over other locally administered NIU treatments such as corticosteroids.
This is a 2020 ARVO Annual Meeting abstract.
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