The first patient has been dosed in a phase 1 clinical trial of OTX-TKI for patients with wet age-related macular degeneration, according to a press release from Ocular Therapeutix.
The multicenter, open-label study of OTX-TKI (tyrosine kinase inhibitor implant) is evaluating its safety, durability and tolerability in wet AMD patients. Biological activity will be evaluated by retinal thickness measurements and visual acuity, the release said.
“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 TKIs act upstream of VEGF inhibitors, we believe this phase 1 trial may bring us one step closer to understanding whether TKIs may represent a next-generation treatment for wet AMD and diabetic macular edema,” Michael Goldstein, MD, Ocular Therapeutix chief medical officer, said in the release.
The procedure took place at the Sydney Retina Clinic in Sydney, Australia.