Ocular Therapeutix Announces First Patient Dosed in US-Based Phase 1 Trial of OTX-TKI for Wet AMD

“We are very excited to have recently begun dosing patients in this U.S. trial,” Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, said in a company news release. “The start of this trial is significant as this will be the first clinical trial that will dose subjects with our single, higher dose, 600 µg implant. While current anti-VEGF treatments are effective, their durability is limited. OTX-TKI has the potential to be a new sustained release administration with 6 months or longer durability and a new mechanism of action for the treatment of patients with wet AMD and other retinal diseases. Based on early data from our Australian phase 1 clinical trial, OTX-TKI has initially demonstrated acceptable tolerability, preliminary biological activity in some patients and durability for up to 6 months or longer in some cases.”

The phase 1 clinical trial in the U.S. is a prospective, randomized, controlled, multicenter trial evaluating a single OTX-TKI implant containing a 600 µg dose of axitinib, compared with a 2 mg dose of aflibercept administered every 8 weeks in subjects previously treated with anti-VEGF therapy. This trial is designed to assess the safety, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. The US-based clinical trial of OTX-TKI is being conducted under an exploratory IND (eIND) application at five sites with a total of 20 randomized subjects: 15 subjects being treated with a single OTX-TKI implant containing 600 µg dose of axitinib in combination with an anti-VEGF induction injection, and 5 subjects being treated at 8-week intervals with a dose of aflibercept.