The early-stage trial assessed the safety, durability, and tolerability of OTX-TKI, and measured biological activity in subjects by measuring BCVA and CSFT of the retina
Ocular Therapeutix has plans to start a pivotal trial of OTX-TKI in wet AMD in Q3 2023. (Credit: Marc Schulte on Unsplash)
Ocular Therapeutix said that its axitinib intravitreal hydrogel implant, OTX-TKI, has delivered positive results in a phase 1 clinical trial in the US in patients with wet age-related macular degeneration (wet AMD).
According to preliminary findings, patients who received a single OTX-TKI implant at 10 months had stable and sustained best corrected visual acuity (BCVA) and central subfield thickness (CSFT).
A total of 21 participants were included in the clinical trial at six US clinical sites. They were randomised 3:1 to two arms, with one of them getting a single OTX-TKI implant and a follow-up 2mg aflibercept injection.
The other group in the trial received injections of aflibercept every eight weeks.
Ocular Therapeutix said that the results from the investigational arm were comparable to the aflibercept arm. The 73% of individuals who were rescue-free as of the seventh month continued to show the extended duration of effect of OTX-TKI till the tenth month.
Overall, OTX-TKI-treated patients experienced a 92% reduction in treatment burden for up to 10 months, said the US-based biopharmaceutical company.
Ocular Therapeutix chief medical officer Rabia Gurses-Ozden said: “We are very encouraged by the interim 10-month data being presented that builds upon the interim 7-month data shared last year at the American Academy of Ophthalmology 2022 Annual Meeting.
“OTX-TKI has been observed to generally be well tolerated with no serious drug-related ocular or systemic adverse events and the visual acuity and retinal thickness outcomes of subjects receiving OTX-TKI in the Phase 1 clinical trial have been comparable to those of subjects receiving aflibercept, while having a substantial reduction in treatment burden.”
The US-based phase 1 clinical trial is a prospective, multi-centre, randomised, controlled study in patients previously treated with anti-VEGF therapy. It is designed to assess the safety, durability and tolerability of OTX-TKI, and to study biological activity in subjects by measuring BCVA and CSFT of the retina.
OTX-TKI is also designed for diabetic retinopathy and other retinal diseases.
The investigational bioresorbable, hydrogel implant has a small molecule called axitinib, which is a multi-target, tyrosine kinase inhibitor having anti-angiogenic features.
Ocular Therapeutix intends to meet with the US Food and Drug Administration (FDA) to talk about potential future clinical trial requirements. The biopharma company intends to launch a pivotal trial in wet AMD in Q3 2023, subject to its discussions with the FDA and securing the required financing.