Policy & Regulation
Ocular Therapeutix reports interim results of US Phase 1 clinical trial of OTX-TKI for wet AMD
27 September 2022 -

Biopharmaceutical Ocular Therapeutix Inc (NASDAQ:OCUL), a provider of therapies for diseases and conditions of the eye, announced on Tuesday that interim 7-month data from its US Phase 1 clinical trial evaluating OTX-TKI, its axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases, demonstrated a favourable safety profile, stable and sustained visual acuity and retinal thickness outcomes, and clinically meaningful reduction in treatment burden.

This clinical trial, designed to assess the safety, durability and tolerability of OTX-TK, is a prospective, multi-centre, randomised controlled study that is evaluating a 600 µg 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 eight weeks in subjects previously treated with anti-VEGF therapy.

The trial assesses biological activity in subjects by measuring visual acuity and anatomical changes of the retina using optical coherence tomography. The clinical trial enrolled a total of 21 subjects at six clinical sites in the US, who were randomised 3:1 to the OTX-TKI arm or the on-label every 8-week aflibercept injection arm.

Interim data from the trial, based on data cutoff of 24 August 2022, showed that the single OTX-TKI implant was generally well tolerated with a favourable safety profile. There were no drug-related ocular or systemic serious adverse events observed. There were no reported adverse events such as elevated IOP, retinal detachment, retinal vasculitis, or implant migration into the anterior chamber observed in the OTX-TKI arm, and no subjects dropped out of either arm.

Wet AMD is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally. It causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF).

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