Positive topline results were announced from a phase 3 study evaluating the efficacy and safety of tarcocimab tedromer in patients with macular edema due to retinal vein occlusion (RVO).
Tarcocimab tedromer is an investigational vascular endothelial growth factor (VEGF) inhibitor designed to improve bioavailability and intraocular half-life using a proprietary antibody biopolymer conjugate platform. The multicenter, randomized, double-masked, active comparator-controlled BEACON study (ClinicalTrials.gov Identifier: NCT04592419) included 568 treatment-naïve adults with vision loss and macular edema due to RVO, including both branch and central subtypes.
Patients were randomly assigned 1:1 to receive tarcocimab tedromer 5mg via intravitreal injection once every 8 weeks following 2 monthly loading doses or aflibercept 2mg via intravitreal injection on a fixed every 4 weeks dosing regimen. The primary endpoint was the change from baseline in best-corrected visual acuity (BVCA) score at week 24.
Findings showed that treatment with tarcocimab tedromer was associated with noninferior visual acuity gains when compared with aflibercept in patients with branch RVO (P =.0004) and in the overall RVO population (P =.0243). The noninferiority margin was established at 4.5 eye chart letters according to pretrial regulatory feedback and precedent.
As for safety, intraocular inflammation was reported in 1.4% of tarcocimab-treated patients and 0.4% of aflibercept-treated patients; vasculitis and retinal arterial occlusion were not observed in either group.
“BEACON is the first study to successfully test a doubling of the treatment interval for anti-VEGF dosing in a pivotal trial in RVO patients,” said Mark Barakat, MD, Director of the Retinal Research Institute at Retinal Consultants of Arizona and a BEACON study investigator. “Testing only 2 loading doses and an extended, fixed dosing interval for all patients rather than assigning a subset of patients to extended dosing based on disease activity assessment is an especially high bar because eyes of patients with RVO can have the highest VEGF levels across retinal vascular diseases.”
Full primary study results are expected at upcoming ophthalmology congresses in September 2022.
- Kodiak Sciences reports positive topline results from BEACON phase 3 study of tarcocimab tedromer (KSI-301) in patients with retinal vein occlusion. News release. Kodiak Sciences. Accessed August 9, 2022. https://www.prnewswire.com/news-releases/kodiak-sciences-reports-positive-topline-results-from-beacon-phase-3-study-of-tarcocimab-tedromer-ksi-301-in-patients-with-retinal-vein-occlusion-301601194.html
- Our Science. Kodiak Sciences. Accessed August 9, 2022. https://kodiak.com/our-science/