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 an extended duration of up to 12 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.
The Company initiated an ex-U.S. Phase 1 clinical trial for OTX-TKI in the 2nd quarter of 2018. The study will be a multi-center, open-label, dose escalation study to test the safety, durability, and tolerability of OTX-TKI. The Company also plans to evaluate biological activity by following visual acuity over time and measuring retinal thickness using standard optical coherence tomography (OCT).
Caution: NEW DRUG – OTX-TKI is currently undergoing clinical evaluation and is limited by law to investigational use only. This product has not been approved by the FDA as safe or effective.
“OTX-TKI has shown sustained and consistent drug levels in pre-clinical testing.”
– Peter Jarrett, Ph.D., Chief Scientific Officer
OTX-TKI fiber to rod. Video shown in real time in simulated vitreous humor.
(eyes of treatment – naïve rabbits)
Our proprietary intravitreal approach demonstrated the ability to deliver TKI to the posterior segment for up to 12 months using an intravitreal bioresorbable hydrogel implant in pre-clinical studies¹
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.