[ ARVO 2025 Meeting Oral Presentation] Dispersed axitinib eye drops showed excellent efficacy in a non-human primate model for Wet AMD
Title : Dispersed axitinib eye drops showed excellent efficacy in a non-human primate model for Wet AMD
Authors : Gwangho Kim, Sungwoo Hwang, Jieun Lee, Hyeon Cho, Kyoung-Hee Kim
Published: 2025 ARVO Meeting Oral Presentation
Investigative Ophthalmology & Visual Science June 2025, Vol.66, 930. doi:
Abstract
Purpose: The burden of intravitreal injections in the treatment of wet AMD patients has led to continued demand for non-invasive treatment methods such as eye drops. Axitinib, a potent and selective VEGF receptor inhibitor, is aqueously dispersed with our proprietary technology as D-AXT. In this study, we evaluated the anti-angiogenic efficacy of D-AXT eye drops in a laser-induced choroidal neovascularization (CNV) model in rhesus monkeys.
Methods: Experimental CNV was induced in the eyes of rhesus monkeys by laser photocoagulation. Monkeys in the D-AXT eye drop groups received 1 drop in the conjunctival sac four times a day for 28 days. Monkeys in the Aflibercept group received a single intravitreal injection (2 mg/eye) on Day 0. Fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) were performed at baseline, Day 14 and Day 28 to assess the number of grade III/IV CNV lesions, the fluorescein leakage area and retinal thickness of grade III/IV CNV lesions.
Results: Treatment with Aflibercept resulted in a complete reduction of the number of grade III/IV CNV lesions, the leakage area and retinal thickness, as expected (p<0.01). D-AXT eye drop groups (0.04%, 0.08%, 0.12%) significantly reduced the number of grade III/IV CNV lesions compared to the vehicle group at both Day 14 and Day 28 (p<0.01). For the CNV leakage area, D-AXT groups exhibited reductions in the range of -17.5% to -54.5% and -36.4% to -61.4% on Day 14 and 28, respectively (p<0.05 or p<0.01). The 0.08% group showed the greatest reduction at both time points. In terms of retinal thickness, D-AXT groups exhibited reductions in retinal thickness ranging from -31.2% to -45.9% and -54.5% to 67.9% on Day 14 and 28, respectively (p<0.05 or p<0.01). In addition, D-AXT eye drops demonstrated no safety concerns throughout the treatment period.
Conclusions: Topical administration of D-AXT eye drops demonstrated significant efficacy and safety in non-human primates, comparable to Aflibercept injection. These results strongly support that D-AXT eye drops can provide a non-invasive solution for patients with wet AMD. We plan to prove the efficacy and safety of D-AXT eye drops in upcoming clinical trials.