OTX-TKI “tyrosine kinase inhibitor” implant

Caution: NEW DRUG – OTX-TKI is currently undergoing clinical evaluation in the United States and is limited by United States law to investigational use only. This product has not been approved by the FDA as safe or effective.

Fluorescein Angiography Images

In a study to characterize the pharmacodynamic efficacy of OTX-TKI delivered via intravitreal injection, eyes of treatment-naïve rabbits were bilaterally dosed with OTX-TKI; eyes were then challenged with an injection of 1 μg vascular endothelial growth factor (VEGF) and were evaluated for leakage by fluorescein angiography following injection for six months.¹

No inhibition of leakage, with fluorescein seen actively leaking from vasculature immediately following injection of VEGF in all rabbits.  Control eyes (without OTX-TKI treatment) showed high tortuosity and leakage at all study time points.¹

Leakage scores in eyes treated with OTX-TKI showed minimal to no vascular leakage at all time points of the study.  A significant reduction in vascular proliferation, tortuosity and leakage in eyes challenged with VEGF over a six month period was observed.¹

Ocular Therapeutix is currently developing sustained-release tyrosine kinase inhibitor (TKI) implants that will be delivered through intravitreal injection.  OTX-TKI “tyrosine kinase inhibitor” implant is a bioresorbable hydrogel that contains TKI particles in an injectable fiber.  OTX-TKI is designed to deliver drug to the target tissues for a period of 6 months, thereby potentially extending the dosing interval from the 1-2 month frequency needed with the current standard of care.  Ocular Therapeutix has performed pharmacokinetic, efficacy, and tolerability preclinical testing on OTX-TKI.

“OTX-TKI has shown sustained and consistent drug levels in pre-clinical testing.”

– Peter Jarrett, Ph.D., Chief Scientific Officer

¹El-Hayek R, et. al. Efficacy of a 6 month Sustained Hydrogel Delivery System for Tyrosine Kinase Inhibitors in a VEGF Induced Retinal Leakage Model. ARVO poster, May 2017. Baltimore, MD.