Axitinib implant well tolerated in wet AMD treatment
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OTX-TKI, a hydrogel-based implant in development for sustained-release delivery of axitinib, has been well tolerated in patients with neovascular age-related macular degeneration, according to a study.
At the virtual Association for Research in Vision and Ophthalmology meeting, James G. Wong, MBBS, of Strathfield Retina Clinic in Australia, said that unmet needs remain in neovascular AMD treatment.
“Therapeutic challenges associated with current therapies include rapid clearance of VEGF inhibitors requiring repeated injections every 1 to 2 months to maintain effective concentrations,” he said. “Even with flexible regimens, multiple visits and injections can be challenging for patients and families, leading to patient nonadherence and nonpersistence.”
Researchers are evaluating three cohorts of patients with neovascular AMD who were either treatment-naive or had a history of anti-VEGF therapy. The first cohort received OTX-TKI 200 µg (Ocular Therapeutix) (six patients). Cohort 2 received 400 µg (seven patients). Cohort 3 is still in enrollment and was further split into two groups: 3a received 600 µg (five of six patients enrolled), and 3b received 400 µg plus anti-VEGF induction therapy (two of six patients enrolled).
Investigators assessed central subfield thickness (CSFT) using spectral-domain OCT, best corrected visual acuity and adverse events, with findings recorded at baseline, injection day, and days 3, 7 and 14 and then monthly until the implants were no longer visible.
As of 9 to 10.5 months in cohort 1 and at least 12 months in cohort 2, researchers have observed no ocular serious adverse events. Additionally, no subject has experienced changes in IOP, and none have required steroids.
While CSFT remained stable in cohort 1, Wong and colleagues found that many patients in cohorts 2 and 3a experienced a decrease in CSFT and demonstrated a reduction in intraretinal fluid or subretinal fluid by 2 months. One patient in cohort 2 maintained this reduction for up to 13 months.
Implants were generally no longer visible by 9 to 10.5 months after injection.
“The OTX-TKI was generally well tolerated,” Wong said. “To date, it has been observed to have a favorable safety profile, with no ocular serious adverse events in treatment-naive and previously treated AMD patient groups.”
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Wong JG, et al. Phase 1 study of an intravitreal axitinib hydrogel-based implant for the treatment of neovascular age-related macular degeneration (nAMD). Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 1-7, 2021 (virtual meeting).
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