OTX-TKI shows durable results in treatment of neovascular AMD
Key takeaways:
- Seventy-three percent of patients treated with OTX-TKI were rescue-free up to 40 weeks.
- OTX-TKI led to an 89% reduction in anti-VEGF treatment burden.
CARLSBAD, Calif. — A sustained-release intravitreal hydrogel implant containing axitinib demonstrated durable results in patients with neovascular age-related macular degeneration, according to phase 1 study results.
The results, presented at the Women in Ophthalmology Summer Symposium, showed patients achieved stable central subfield thickness (CSFT) and best corrected visual acuity for up to 52 weeks.
Tyrosine kinase inhibitors such as axitinib may offer a broader antiangiogenic profile for the treatment of neovascular AMD compared with current anti-VEGF therapies, which require repeated intravitreal injections that can lead to adverse events and poor long-term tolerance, according to Lejla Vajzovic, MD, FASRS, of Duke University Eye Center.
The double-masked prospective study assessed the efficacy of Axpaxli (axitinib intravitreal implant, Ocular Therapeutix), also known as OTX-TKI, in 20 previously treated patients with neovascular AMD and controlled fluid. They were randomly assigned 3:1 to receive OTX-TKI on day 1 and aflibercept 2 mg intravitreal injection at week 4 or aflibercept 2 mg intravitreal injection every 8 weeks.
BCVA, CSFT and rate of anti-VEGF rescue served as the study outcomes. Criteria for rescue anti-VEGF injection included loss of at least 10 letters from the patient’s best previous BCVA, with the current BCVA worse than baseline; evidence of 75 µm or greater CSFT increase from previous best value and five or more letters lost from previous best BCVA; or new macular hemorrhage.
Seventy-three percent of patients treated with OTX-TKI were rescue-free up to 40 weeks, and 60% were rescue-free up to 52 weeks, leading to an 89% reduction in anti-VEGF treatment burden.
Mean change in BCVA appeared comparable between patients who received OTX-TKI (–1 ± 6 letters) or aflibercept (2 ± 7.2 letters), as did mean change in CSFT (20.2 ± 41.6 µm vs. –2.2 ± 8.5 µm).
When censoring patients in the OTX-TKI group who received anti-VEGF rescue, results appeared similar for BCVA (0.6 ± 2.6 letters) and CSFT (17.2 ± 47.6 µm).
No ocular or systemic serious adverse events occurred in patients who received OTX-TKI.
“OTX-TKI-treated patients maintained stable CSFT and BCVA up to 52 weeks, comparable with standard-of-care aflibercept,” Vajzovic wrote.
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Vajzovic L. 52-week rescue-free patients treated with axitinib hydrogel implant (OTX-TKI) in the US phase 1 clinical trial for nAMD. Presented at: Women in Ophthalmology Summer Symposium; August 22-25, 2024; Carlsbad, California.
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