Ocular Therapeutix announced the dosing of the first patient in a phase 1 trial of OTX-TKI (tyrosine kinase inhibitor implant) in patients with wet age-related macular degeneration (AMD). The first patient was dosed at the Sydney Retina Clinic in Sydney, Australia.
“We are excited to announce the first patient has been successfully dosed in our phase 1 program with OTX-TKI, our tyrosine kinase inhibitor implant for the treatment of serious retinal disease,” Michael Goldstein, MD, Chief Medical Officer at Ocular Therapeutix, said in a company news release. “Our trial is primarily intended to demonstrate safety, but we will also evaluate biological activity in patients with increased retinal thickness and measure whether there are decreases over time. Given that TKI’s act upstream of VEGF inhibitors, we believe this phase 1 trial may bring us one step closer to understanding whether TKI’s may represent a next-generation treatment for wet AMD and diabetic macular edema.”
The phase 1 trial is a multicenter, open-label study testing the safety, durability, and tolerability of OTX-TKI, a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor delivered by intravitreal injection to patients with wet AMD. The study will evaluate biological activity by measuring retinal thickness using standard optical coherence tomography and following visual acuity over time.
About OTX-TKI (tyrosine kinase inhibitor implant) Intravitreal Injection
OTX-TKI is a bioresorbable hydrogel formulated with TKI particles in an injectable fiber that can be delivered through a small-gauge, sterile injection needle to the back of the eye. OTX-TKI is designed to deliver drug to the target tissues for a period of up to 9 months, thereby potentially extending the dosing interval from the 1- to 2-month frequency needed with the current standard of care. Preclinical data have demonstrated the ability to deliver TKI to the posterior segment of the eye with sustained pharmacokinetic/pharmacodynamic effect for the treatment of VEGF-induced retinal leakage for a duration of up to 12 months.