Ocular Therapeutix announces interim 10-month data from Phase 1 OTX-TKI trial

Ocular Therapeutix announced interim 10-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the company’s axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration, diabetic retinopathy and other retinal diseases. The ongoing U.S.-based Phase 1 clinical trial is a prospective, multi-center, randomized, controlled study in subjects previously treated with anti-VEGF therapy that is evaluating a 600 microgram dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks. The trial is designed to assess the safety, durability and tolerability of OTX-TKI, and to assess biological activity in subjects by measuring best corrected visual acuity and central subfield thicknessof the retina. The clinical trial enrolled a total of 21 subjects at six clinical sites in the U.S., who were randomized 3:1 to an arm receiving a single OTX-TKI implant, with a 2 mg aflibercept injection after implant, and an arm receiving aflibercept injections every 8 weeks. One subject in the OTX-TKI arm was not treated per protocol and has been removed from the efficacy analysis, as the subject incorrectly received aflibercept instead of a sham injection at Month 3 and 5 visits. As of the data cutoff of December 12, 2022, in the U.S.-based Phase 1 clinical trial, the single OTX-TKI implant continued to be generally well tolerated with no drug-related ocular or systemic serious adverse events observed through 10 months. As the company previously announced at the 7-month readout, one SAE of endophthalmitis was observed in the OTK-TKI arm which occurred following the mandated aflibercept injection at Month 1 and was assessed by the investigator as related to the injection procedure. There were no elevated IOP, retinal detachment, retinal vasculitis, or implant migration into the anterior chamber adverse events observed in the OTX-TKI arm, and no subjects had dropped out of either arm as of the data cutoff. The interim results showed subjects treated with a single OTX-TKI implant demonstrated stable and sustained and CSFT in the OTX-TKI arm at 10 months, which was comparable with the aflibercept arm. The 73% of subjects who were rescue-free up to Month 7, continued to demonstrate OTX-TKI’s extended duration of action and remained rescue-free up to Month 10. Overall, a 92% reduction in treatment burden was observed in OTX-TKI treated subjects for up to 10 months.